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IEC 60601-2-31:2008+AMD1:2011 CSV
Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source- 발행일 : 2011-09-29
- 발행기관 : IEC
- 대체표준 : IEC 60601-2-31:2020
상세정보
| 분야 | TC 62/SC 62D : Particular medical equipment, software, and systems |
|---|---|
| 적용범위 | IEC 60601-2-31:2008+A1:2011 consists of the second edition (2008) and its amendment 1 (2011). The technical content is therefore identical to the base edition and its amendment and has been prepared for user convenience. IEC 60601-2-31:2008 applies to the basic safety and essential performance of external pacemakers powered by an internal electrical power source. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of external cardiac pacemakers with an internal power source. This particular standard amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. This second edition cancels and replaces the first edition published in 1994 and its Amendment 1 (1998). This second edition of IEC 60601-2-31 is aligned with IEC 60601-1:2005, and contains minimal technical revisions from the first edition. IEC 60601-2-31 Amendment 1:2011 addresses the comments received during the process of harmonizing the standard in Europe, updates several references to defined terms that were not printed in small caps, and improves terminology usage. This consolidated version consists of the second edition (2008) and its amendment 1 (2011). Therefore, no need to order amendment in addition to this publication. |
| 국제분류(ICS)코드 | 11.040.01 : 일반 의료장비 |
| 페이지수 | 77 |
| Edition | 2.1 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC 60601-2-31:2020 RLV상세보기 | Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source | 2020-01-17 | 표준 |
| 2 | IEC 60601-2-31:2020상세보기 | Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source | 2020-01-17 | 표준 |
| 3 | IEC 60601-2-31:2008+AMD1:2011 CSV상세보기 | Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source | 2011-09-29 | 구판 |
| 4 | IEC 60601-2-31:2008/AMD1:2011상세보기 | Amendment 1 - Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source | 2011-06-29 | 구판 |
| 5 | IEC 60601-2-31:2008상세보기 | Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source | 2008-03-26 | 구판 |
| 6 | IEC 60601-2-31:1994/AMD1:1998상세보기 | Amendment 1 - Medical electrical equipment - Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source | 1998-01-01 | 구판 |
| 7 | IEC 60601-2-31:1994상세보기 | Medical electrical equipment - Part 2: Particular requirements for the safety of external cardiac pacemakers with internal power source | 1994-10-12 | 구판 |
관련상품
- IEC/DIS 60601-2-26 - Medical electrical equipment — Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
- IEC 60601-2-15:1988 - Medical electrical equipment. Part 2: Particular requirements for the safety of capacitor discharge X-ray generators
- IEC 60601-2-14:1989 - Medical electrical equipment. Part 2: Particular requirements for the safety of electroconvulsive therapy equipment
- IEC 60601-2-32:1994 - Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment
- IEC 60601-1-4:1996 - Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems
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