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ISO13485医疗器械认证所需国际、国家标准汇编！

  Aaron ·  2008-04-12 15:17  ·  44678 次点击
ISO标准名称标准号版本标准名称
ISO90012000INTERNATIONALSTANDARD
Qualitymanagementsystems-Requirements
ISO116072003
Packagingforterminallysterilizedmedicaldevices
ISO111371995INTERNATIONALSTANDARD
Sterilizationofhealthcareproducts-Requirementforvalidationandroutinecontrol-Radiationsterilization
ISO151972003INTERNATIONALSTANDARD
Invitrodiagnostictestsystems-Requirementsforblood-glucosemonitoringsystemsforself-testinginmanagingdiabetesmellitus
ISO134852003医疗器械
质量管理体系用于法规的要求
ISO/DIS134852003
Qualitymanagementsystems-Medicaldevices-
Systemrequirementsforregulatorypurposes
ISO14971-11998
医疗器械-风险管理-第一部分风险分析的应用
ISO14155-12003INTERNATIONALSTANDAR
Clinicalinvestigationofmedicaldevicesforhumansubjects-Part1:Generalrequirements
ISO14155-22003INTERNATIONALSTANDARD
Clinicalinvestigationofmedicaldevicesforhumansubjects-Part2:Clinicalinvestigationplans
iso13485, 医疗器械, 认证, 所需, 国际, 国家标准, 汇编

6 条回复

Aaron  2008-04-12 15:25
资料汇编见附件
Aaron  2008-04-12 15:22
一次性使用器具标准汇编标准号 版本 标准名称

GB8368
1998
一次性使用输液器

GB8369
1998
一次性使用输血器

GB14232
1993
一次性使用塑料血袋

GB15810
2001
一次性使用无菌注射器

GB15811
2001
一次性使用无菌注射针

GB18458.1
2001
专用输液器 第1部分：一次性使用精密过滤输液器

GB18671
2002
一次性静脉输液针

YY0115
1993
一次性使用采用器

YY0285.1
1999
一次性使用无菌血管内导管 第1部分：通用要求

YY0285.2
1999
一次性使用无菌血管内导管 第2部分：造影导管

YY0285.3
1999
一次性使用无菌血管内导管 第3部分：中心静脉导管

YY0285.4
1999
一次性使用无菌血管内导管 第4部分：球囊扩张导管

YY0285.5
1999
一次性使用无菌血管内导管 第5部分：套针外周导管

YY0286
1996
一次性使用滴定管式输液器

YY/T0289
1996
一次性使用微量采血吸管

YY0311
1998
一次性使用血路产品通用技术条件

YY0314
1999
一次性使用静脉血样采集容器

YY0321.1
2000
一次性使用麻醉穿刺包

YY0321.2
2000
一次性使用麻醉用针

YY0321.3
2000
一次性使用麻醉用过滤器

YY0326.1
2002
一次性使用离心式血浆分离器 第1部分：血浆分离杯

YY0326.2
2002
一次性使用离心式血浆分离器 第2部分：血浆管路

YY0327
2002
一次性使用紫外线透疗血液容器

YY0328
2002
一次性使用机用采血器

YY0329
2002
一次性使用去白细胞滤器

GB/T1962.1
2001
注射器、注射针及其他医疗器械6%（鲁尔）圆锥接头 第1部分：通用要赤

GB/T1962.2
2001
注射器、注射针及其他医疗器械6%（鲁尔）圆锥接头 第1部分：锁定接头

GB12256
1990
注射针针管刚度试验方法

GB/T14233.1
1998
医用输液、输血、注射器具检验方法 第1部分：化学分析方法

GB/T14233.2
1993
医用输液、输血、注射器具检验方法 第二部分：生物试验方法

GB/T16886.1
2001
医疗器械生物学评价 第1部分：评价与试验

GB18278
2000
医疗保健产品灭菌 确认和常规控制要求 工业湿热灭菌

GB18279
2000
医疗器械 环氧乙烷灭菌 确认和常规控制

GB18280
2000
医疗保健产品灭菌 确认和常规控制要求 辐射灭菌

GB18281.1
2000
医疗保健产品灭菌 生物指示物 第1部分：通则

GB18281.2
2000
医疗保健产品灭菌 生物指示物 第2部分：环氧乙烷灭菌用生物指示物

GB18281.3
2000
医疗保健产品灭菌 生物指示物 第3部分：湿热灭菌用生物指示物

GB18282.1
2000
医疗保健产品灭菌 化学批示物 第1部分：通则

YY/T0149
1993
不锈钢医用器械耐磨蚀性能试验方法

GB191
2000
包装储运图示标志

GB/T16292
1996
医药工业洁净室（区）悬浮粒子的方法

GB/T16293
1996
医药工业洁净室（区）浮游菌的测试方法

GB/T16294
1996
医药工业洁净室（区）沉降菌的测试方法

GB15593
1995
输血（液）器具用软聚氯乙烯塑料

GB18457
2001
制造医疗器械用不锈钢针管

YY0033
2000
无菌医疗器具生产管理规范

YY0114
1993
医用输液、输血、注射器用聚乙烯专用料

YY0242
1996
医用输液、输血、注射器用聚乙烯专用料

YY/T0243
1996
一次性使用无菌注射器用橡胶活塞

YY/T0296
1997
一次性使用注射针 识别色标

YY/T0313
1998
医用高分子制品包装、标志、运输和贮存
Aaron  2008-04-12 15:21
GB/YY国家标准标准号 版本 标准名称

YY/T0287
2003
质量体系——医疗器械 GB/T19001-ISO9001应用的专用要求

YY/T0297
1998
医疗器械临床调查

YY/T0316
2003
医疗器械 风险管理对医疗器械的应用

GB15980
1995
一次性使用医疗用品卫生标准

GB/15981
1995
消毒与灭菌效果的评价方法与标准

GB/T16292~16294
1996
医药工业洁净室（区）悬浮粒子、浮游菌和沉降菌的测试方法

GB/T16886.1
1997
医疗设备的生物学评估 第1部分：试验选择指南

GB/T18279
2000
医疗器械 环氧乙烷灭菌 确认和常规控制

GB/T19001
1994
质量体系设计、开发、生产、安装和服务的质量保证模式

GB/T19000

GB/T19001

GB/T19004
2000
质量管理体系标准
Aaron  2008-04-12 15:21
AIMDD

欧洲标准组织 标准编号和名称 被取代标准 失效日期

CEN
EN 550:1994

Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization
—


CEN
EN 552:1994

Sterilization of medical devices - Validation and routine control of sterilization by irradiation
—


CEN
EN 554:1994

Sterilization of medical devices - Validation and routine control of sterilization by moist heat
—


CEN
EN 556-1:2001

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN 556:1994 + A1:1998
Date Expired

(30.4.2002)

CEN
EN 556-2:2003

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
—


CEN
EN 868-1:1997

Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods
—


CEN
EN 980:2003

Graphical symbols for use in the labelling of medical devices
EN 980:1996
Date Expired

(31.10.2003)

CEN
EN 1041:1998

Information supplied by the manufacturer with medical devices
—


CEN
EN 1174-1:1996

Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: Requirements
—


CEN
EN 1174-2:1996

Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 2: Guidance
—


CEN
EN 1174-3:1996

Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 3: Guide to the methods for validation of microbiological techniques
—


CEN
EN ISO 10993-1:2003

Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)
—


CEN
EN ISO 10993-4:2002

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002)
EN 30993-4:1993
Date Expired

(30.4.2003)

CEN
EN ISO 10993-5:1999

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)
EN 30993-5:1994
Date Expired

(30.11.1999)

CEN
EN ISO 10993-9:1999

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)
—


CEN
EN ISO 10993-10:2002

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002)
EN ISO 10993-10:1995
Date Expired

(31.3.2003)

CEN
EN ISO 10993-11:1995

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:1993)
—


CEN
EN ISO 10993-12:2004

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2002)
EN ISO 10993-12:1996
Date Expired

(31.5.2005)

CEN
EN ISO 10993-13:1998

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)
—


CEN
EN ISO 10993-16:1997

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)
—


CEN
EN ISO 10993-17:2002

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
—


CEN
EN ISO 10993-18:2005

Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
—


CEN
EN ISO 11140-1:2005

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)
—


CEN
EN ISO 13485:2003

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
EN ISO 13485:2000

EN ISO 13488:2000
31.7.2006

CEN
EN 13824:2004

Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
—


CEN
EN ISO 14155-1:2003

Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
EN 540:1993
Date Expired

(31.8.2003)

CEN
EN ISO 14155-2:2003

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
—


CEN
EN ISO 14971:2000

Medical devices - Application of risk management to medical devices (ISO 14971:2000)
EN 1441:1997
Date Expired

(31.3.2004)


EN ISO 14971:2000/A1:2003
Note 3
Date Expired

(31.3.2004)

CEN
EN 30993-6:1994

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:1994)
—


CEN
EN 45502-1:1997

Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
—


CEN
EN 45502-2-1:2004

Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
Aaron  2008-04-12 15:20
IVDD

欧洲标准组织 标准编号和名称 被取代标准 失效日期

CEN
EN 375:2001

Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
—


CEN
EN 376:2002

Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
—


CEN
EN 556-1:2001

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN 556:1994 + A1:1998
Date Expired

(30.4.2002)

CEN
EN 591:2001

Instructions for use for in vitro diagnostic instruments for professional use
—


CEN
EN 592:2002

Instructions for use for in vitro diagnostic instruments for self-testing
—


CEN
EN 794-1:1997

Lung ventilators - Part 1: Particular requirements for critical care ventilators
—



EN 794-1:1997/A1:2000
Note 3
Date Expired

(31.5.2001)

CEN
EN 980:2003

Graphical symbols for use in the labelling of medical devices
EN 980:1996
Date Expired

(31.10.2003)

CEN
EN 1280-1:1997

Agent specific filling systems for anaesthetic vaporizers - Part 1: Rectangular keyed filling systems
—



EN 1280-1:1997/A1:2000
Note 3
Date Expired

(24.11.2000)

CEN
EN ISO 4135:2001

Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001)
—


CEN
EN 12286:1998

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures
—



EN 12286:1998/A1:2000
Note 3
Date Expired

(24.11.2000)

CEN
EN 12287:1999

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials
—


CEN
EN 12322:1999

In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
—



EN 12322:1999/A1:2001
Note 3
Date Expired

(30.4.2002)

CEN
EN ISO 13485:2003

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
EN ISO 13488:2000

EN ISO 13485:2000
31.7.2006

CEN
EN 13532:2002

General requirements for in vitro diagnostic medical devices for self-testing
—


CEN
EN 13612:2002

Performance evaluation of in vitro diagnostic medical devices
—


CEN
EN 13640:2002

Stability testing of in vitro diagnostic reagents
—


CEN
EN 13641:2002

Elimination or reduction of risk of infection related to in vitro diagnostic reagents
—


CEN
EN 13975:2003

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
—


CEN
EN 14254:2004

In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
—


CEN
EN 14820:2004

Single-use containers for human venous blood specimen collection
—


CEN
EN ISO 14937:2000

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000)
—


CEN
EN ISO 14971:2000

Medical devices - Application of risk management to medical devices (ISO 14971:2000)
—



EN ISO 14971:2000/A1:2003
Note 3
Date Expired

(31.3.2004)

CEN
EN ISO 15197:2003

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)
—


CEN
EN ISO 15225:2000

Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000)
—


CEN
EN ISO 17511:2003

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)
—


CEN
EN ISO 18153:2003

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)
—


CENELEC
EN 61010-2-101: 2002

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

Reference document: IEC 61010-2-101:2002 (Modified)
—
Aaron  2008-04-12 15:19
CEN
EN ISO 14408:2005

Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005)
—


CEN
EN ISO 14534:2002

Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002)
EN ISO 14534:1997
Date Expired

(31.12.2002)

CEN
EN ISO 14602:1998

Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)
—


CEN
EN ISO 14630:2005

Non-active surgical implants - General requirements (ISO 14630:2005)
EN ISO 14630:1997
30.11.2005

CEN
EN ISO 14889:2003

Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003)
EN ISO 14889:1997
Date Expired

(30.11.2003)

CEN
EN ISO 14937:2000

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000)
—


CEN
EN ISO 14971:2000

Medical devices - Application of risk management to medical devices (ISO 14971:2000)
EN 1441:1997
Date Expired

(31.3.2004)


EN ISO 14971:2000/A1:2003
Note 3
Date Expired

(31.3.2004)

CEN
EN ISO 15001:2004

Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2003)
—


CEN
EN ISO 15004:1997

Ophthalmic instruments - Fundamental requirements and test methods (ISO 15004:1997)
—


CEN
EN ISO 15225:2000

Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000)
—



EN ISO 15225:2000/A1:2004
Note 3
Date Expired

(31.8.2004)

CEN
EN ISO 15747:2005

Plastics containers for intravenous injection (ISO 15747:2003)
—


CEN
EN ISO 17510-1:2002

Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy devices (ISO 17510-1:2002)
—


CEN
EN ISO 17510-2:2003

Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2003)
—


CEN
EN ISO 17664:2004

Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)
—


CEN
EN ISO 18777:2005

Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)
—


CEN
EN ISO 18778:2005

Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
—


CEN
EN ISO 18779:2005

Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005)
—


CEN
EN 20594-1:1993

Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)
—



EN 20594-1:1993/A1:1997
Note 3
Date Expired

(31.5.1998)

CEN
EN ISO 21647:2004

Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004)
EN ISO 11196:1997

EN 12598:1999
Date Expired

(31.5.2005)

CEN
EN ISO 22612:2005

Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005)
—


CEN
EN 27740:1992

Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)
—



EN 27740:1992/A1:1997
Note 3
Date Expired

(31.5.1998)

CEN
EN 30993-6:1994

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:1994)
—


CEN/ CENELEC
EN 46003:1999

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003
—


CENELEC
EN 60118-13:1997

Hearing aids --

Part 13: Electromagnetic compatibility (EMC)

(IEC 60118-13:1997)

NONE

-

CENELEC
EN 60118-13:2005

Electroacoustics - Hearing aids --

Part 13: Electromagnetic compatibility (EMC)

(IEC 60118-13:2004)

EN 60118-13:1997
Note 2.1

01.02.2008

CENELEC
EN 60522:1999

Determination of the permanent filtration of X-ray tube assemblies

(IEC 60522:1999)

NONE

-

CENELEC
EN 60580:2000

Medical electrical equipment - Dose area product meters

(IEC 60580:2000)

NONE

-

CENELEC
EN 60601-1:1990

Medical electrical equipment --

Part 1: General requirements for safety

(IEC 60601-1:1988)

NONE

-




Amendment A1:1993 to EN 60601-1:1990

(IEC 60601-1:1988/A1:1991)


Note 3


-




Amendment A2:1995 to EN 60601-1:1990

(IEC 60601-1:1988/A2:1995)


Note 3


-




Amendment A13:1996 to EN 60601-1:1990


Note 3


Date expired (01.07.1996)






CENELEC
EN 60601-1-1:2001

Medical electrical equipment --

Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems

(IEC 60601-1-1:2000)

EN 60601-1-1:1993
+A1:1996
Note 2.1

Date expired (01.12.2003)

CENELEC
EN 60601-1-2:2001

Medical electrical equipment --

Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests

(IEC 60601-1-2:2001)

EN 60601-1-2:1993
Note 2.1

Date expired (01.11.2004)

CENELEC
EN 60601-1-3:1994

Medical electrical equipment --

Part 1: General requirements for safety --

3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment

(IEC 60601-1-3:1994)

NONE

-

CENELEC
EN 60601-1-4:1996

Medical electrical equipment --

Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems

(IEC 60601-1-4:1996)

NONE

-




Amendment A1:1999 to EN 60601-1-4:1996

(IEC 60601-1-4:1996/A1:1999)


Note 3


Date expired (01.12.2002)






CENELEC
EN 60601-2-1:1998

Medical electrical equipment --

Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV

(IEC 60601-2-1:1998)

NONE

-




Amendment A1:2002 to EN 60601-2-1:1998

(IEC 60601-2-1:1998/A1:2002)


Note 3


Date expired (01.06.2005)






CENELEC
EN 60601-2-2:2000

Medical electrical equipment --

Part 2-2: Particular requirements for the safety of high frequency surgical equipment

(IEC 60601-2-2:1998)

EN 60601-2-2:1993
Note 2.1

Date expired (01.08.2003)

CENELEC
EN 60601-2-3:1993

Medical electrical equipment --

Part 2: Particular requirements for the safety of short-wave therapy equipment

(IEC 60601-2-3:1991)

NONE

-




Amendment A1:1998 to EN 60601-2-3:1993

(IEC 60601-2-3:1991/A1:1998)


Note 3


Date expired (01.07.2001)






CENELEC
EN 60601-2-4:2003

Medical electrical equipment --

Part 2-4: Particular requirements for the safety of cardiac defibrillators

(IEC 60601-2-4:2002)

NONE

-

CENELEC
EN 60601-2-5:2000

Medical electrical equipment --

Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment

(IEC 60601-2-5:2000)

NONE

-

CENELEC
EN 60601-2-7:1998

Medical electrical equipment --

Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators

(IEC 60601-2-7:1998)

NONE

-

CENELEC
EN 60601-2-8:1997

Medical electrical equipment --

Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

(IEC 60601-2-8:1987)

NONE

-




Amendment A1:1997 to EN 60601-2-8:1997

(IEC 60601-2-8:1987/A1:1997)


Note 3


Date expired (01.06.1998)






CENELEC
EN 60601-2-9:1996

Medical electrical equipment --

Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors

(IEC 60601-2-9:1996)

NONE

-

CENELEC
EN 60601-2-10:2000

Medical electrical equipment --

Part 2-10: Particular requirements for the safety of nerve and muscle stimulators

(IEC 60601-2-10:1987)

NONE

-




Amendment A1:2001 to EN 60601-2-10:2000

(IEC 60601-2-10:1987/A1:2001)


Note 3


Date expired (01.11.2004)






CENELEC
EN 60601-2-11:1997

Medical electrical equipment --

Part 2-11: Particular requirements for the safety of gamma beam therapy equipment

(IEC 60601-2-11:1997)

NONE

-




Amendment A1:2004 to EN 60601-2-11:1997

(IEC 60601-2-11:1997/A1:2004)


Note 3


01.09.2007






CENELEC
EN 60601-2-16:1998

Medical electrical equipment --

Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment

(IEC 60601-2-16:1998)

NONE

-

CENELEC
EN 60601-2-17:1996

Medical electrical equipment --

Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray after-loading equipment

(IEC 60601-2-17:1989)

NONE

-




Amendment A1:1996 to EN 60601-2-17:1996

(IEC 60601-2-17:1989/A1:1996)


Note 3


Date expired (01.03.1997)






CENELEC
EN 60601-2-17:2004

Medical electrical equipment --

Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment

(IEC 60601-2-17:2004)

EN 60601-2-17:1996
and its amendment
Note 2.1

01.03.2007

CENELEC
EN 60601-2-18:1996

Medical electrical equipment --

Part 2: Particular requirements for the safety of endoscopic equipment

(IEC 60601-2-18:1996)

NONE

-




Amendment A1:2000 to EN 60601-2-18:1996

(IEC 60601-2-18:1996/A1:2000)


Note 3


Date expired (01.08.2003)






CENELEC
EN 60601-2-19:1996

Medical electrical equipment --

Part 2: Particular requirements for the safety of baby incubators

(IEC 60601-2-19:1990)

NONE

-




Amendment A1:1996 to EN 60601-2-19:1996

(IEC 60601-2-19:1990/A1:1996)


Note 3


Date expired (13.06.1998)






CENELEC
EN 60601-2-20:1996

Medical electrical equipment --

Part 2: Particular requirements for the safety of transport incubators

(IEC 60601-2-20:1990 + A1:1996)

NONE

-

CENELEC
EN 60601-2-21:1994

Medical electrical equipment --

Part 2: Particular requirements for the safety of infant radiant warmers

(IEC 60601-2-21:1994)

NONE

-




Amendment A1:1996 to EN 60601-2-21:1994

(IEC 60601-2-21:1994/A1:1996)


Note 3


Date expired (13.06.1998)






CENELEC
EN 60601-2-22:1996

Medical electrical equipment --

Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment

(IEC 60601-2-22:1995)

NONE

-

CENELEC
EN 60601-2-23:2000

Medical electrical equipment --

Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment

(IEC 60601-2-23:1999)

EN 60601-2-23:1997
Note 2.1

Date expired (01.01.2003)

CENELEC
EN 60601-2-24:1998

Medical electrical equipment --

Part 2-24: Particular requirements for the safety of infusion pumps and controllers

(IEC 60601-2-24:1998)

NONE

-

CENELEC
EN 60601-2-25:1995

Medical electrical equipment --

Part 2-25: Particular requirements for the safety of electrocardiographs

(IEC 60601-2-25:1993)

NONE

-




Amendment A1:1999 to EN 60601-2-25:1995

(IEC 60601-2-25:1993/A1:1999)


Note 3


Date expired (01.05.2002)






CENELEC
EN 60601-2-26:1994

Medical electrical equipment --

Part 2: Particular requirements for the safety of electroencephalographs

(IEC 60601-2-26:1994)

NONE

-

CENELEC
EN 60601-2-26:2003

Medical electrical equipment --

Part 2-26: Particular requirements for the safety of electroencephalographs

(IEC 60601-2-26:2002)

EN 60601-2-26:1994
Note 2.1

01.03.2006

CENELEC
EN 60601-2-27:1994

Medical electrical equipment --

Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment

(IEC 60601-2-27:1994)

NONE

-

CENELEC
EN 60601-2-28:1993

Medical electrical equipment --

Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis

(IEC 60601-2-28:1993)

NONE

-

CENELEC
EN 60601-2-29:1999

Medical electrical equipment --

Part 2-29: Particular requirements for the safety of radiotherapy simulators

(IEC 60601-2-29:1999)

EN 60601-2-29:1995
+A1:1996
Note 2.1

Date expired (01.04.2002)

CENELEC
EN 60601-2-30:2000

Medical electrical equipment --

Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment

(IEC 60601-2-30:1999)

EN 60601-2-30:1995
Note 2.1

Date expired (01.02.2003)

CENELEC
EN 60601-2-31:1995

Medical electrical equipment --

Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source

(IEC 60601-2-31:1994)

NONE

-




Amendment A1:1998 to EN 60601-2-31:1995

(IEC 60601-2-31:1994/A1:1998)


Note 3


Date expired (01.01.2001)






CENELEC
EN 60601-2-32:1994

Medical electrical equipment --

Part 2: Particular requirements for the safety of associated equipment of X-ray equipment

(IEC 60601-2-32:1994)

NONE

-

CENELEC
EN 60601-2-33:2002

Medical electrical equipment --

Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis

(IEC 60601-2-33:2002)

EN 60601-2-33:1995
+A11:1997
Note 2.1

Date expired (01.07.2005)

CENELEC
EN 60601-2-34:2000

Medical electrical equipment --

Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment

(IEC 60601-2-34:2000)

EN 60601-2-34:1995
Note 2.1

Date expired (01.11.2003)

CENELEC
EN 60601-2-35:1996

Medical electrical equipment --

Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use

(IEC 60601-2-35:1996)

NONE

-

CENELEC
EN 60601-2-36:1997

Medical electrical equipment --

Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy

(IEC 60601-2-36:1997)

NONE

-

CENELEC
EN 60601-2-37:2001

Medical electrical equipment --

Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment

(IEC 60601-2-37:2001)

NONE

-




Amendment A1:2005 to EN 60601-2-37:2001

(IEC 60601-2-37:2001/A1:2004)


Note 3


01.01.2008






CENELEC
EN 60601-2-38:1996

Medical electrical equipment --

Part 2-38: Particular requirements for the safety of electrically operated hospital beds

(IEC 60601-2-38:1996)

NONE

-




Amendment A1:2000 to EN 60601-2-38:1996

(IEC 60601-2-38:1996/A1:1999)


Note 3


Date expired (01.01.2003)






CENELEC
EN 60601-2-39:1999

Medical electrical equipment --

Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment

(IEC 60601-2-39:1999)

NONE

-

CENELEC
EN 60601-2-40:1998

Medical electrical equipment --

Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment

(IEC 60601-2-40:1998)

NONE

-

CENELEC
EN 60601-2-41:2000

Medical electrical equipment --

Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis

(IEC 60601-2-41:2000)

NONE

-

CENELEC
EN 60601-2-43:2000

Medical electrical equipment --

Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures

(IEC 60601-2-43:2000)

NONE

-

CENELEC
EN 60601-2-44:2001

Medical electrical equipment --

Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography

(IEC 60601-2-44:2001)

EN 60601-2-44:1999
Note 2.1

Date expired (01.07.2004)




Amendment A1:2003 to EN 60601-2-44:2001

(IEC 60601-2-44:2001/A1:2002)


Note 3


Date expired (01.12.2005)






CENELEC
EN 60601-2-45:2001

Medical electrical equipment --

Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices

(IEC 60601-2-45:2001)

EN 60601-2-45:1998
Note 2.1

Date expired (01.07.2004)

CENELEC
EN 60601-2-46:1998

Medical electrical equipment --

Part 2-46: Particular requirements for the safety of operating tables

(IEC 60601-2-46:1998)

NONE

-

CENELEC
EN 60601-2-47:2001

Medical electrical equipment --

Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems

(IEC 60601-2-47:2001)

NONE

-

CENELEC
EN 60601-2-49:2001

Medical electrical equipment --

Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment

(IEC 60601-2-49:2001)

NONE

-

CENELEC
EN 60601-2-50:2002

Medical electrical equipment --

Part 2-50: Particular requirements for the safety of infant phototherapy equipment

(IEC 60601-2-50:2000)

NONE

-

CENELEC
EN 60601-2-51:2003

Medical electrical equipment --

Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

(IEC 60601-2-51:2003)

NONE

-

CENELEC
EN 60627:2001

Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids

(IEC 60627:2001)

NONE

-

CENELEC
EN 60645-1:2001

Electroacoustics - Audiological equipment --

Part 1: Pure-tone audiometers

(IEC 60645-1:2001)

EN 60645-1:1994
Note 2.1

Date expired (01.10.2004)

CENELEC
EN 60645-2:1997

Audiometers --

Part 2: Equipment for speech audiometry

(IEC 60645-2:1993)

NONE

-

CENELEC
EN 60645-3:1995

Audiometers --

Part 3: Auditory test signals of short duration for audiometric and neuro-otological purposes

(IEC 60645-3:1994)

NONE

-

CENELEC
EN 60645-4:1995

Audiometers --

Part 4: Equipment for extended high-frequency audiometry

(IEC 60645-4:1994)

NONE

-

CENELEC
EN 61217:1996

Radiotherapy equipment - Coordinates, movements and scales

(IEC 61217:1996)

NONE

-




Amendment A1:2001 to EN 61217:1996

(IEC 61217:1996/A1:2000)


Note 3


Date expired (01.12.2003)






CENELEC
EN 61223-3-1:1999

Evaluation and routine testing in medical imaging departments --

Part 3-1: Acceptance tests - Imaging performance of X-ray equipment for radiographic and radioscopic systems

(IEC 61223-3-1:1999)

NONE

-

CENELEC
EN 61223-3-4:2000

Evaluation and routine testing in medical imaging departments --

Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment

(IEC 61223-3-4:2000)

NONE

-

CENELEC
EN 61676:2002

Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology

(IEC 61676:2002)

NONE

-

CENELEC
EN 62083:2001

Medical electrical equipment --

Requirements for the safety of radiotherapy treatment planning systems

(IEC 62083:2000)

NONE

-

CENELEC
EN 62220-1:2004

Medical electrical equipment - Characteristics of digital X-ray imaging devices --

Part 1: Determination of the detective quantum efficiency

(IEC 62220-1:2003)

NONE

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