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【資料１】次世代医療機器評価指標について (40 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/newpage_32218.html |
| 出典情報 | 薬事・食品衛生審議会 医療機器・体外診断薬部会（令和4年度第10回 3／27）《厚生労働省》 |
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37.ISO 14160; 1998, Sterilization of single-use medical devices incorporating
materials of animal origin – Validation and routine control of sterilization
by liquid sterilants
38.ISO 14937, 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
39.ISO 17664, Sterilization of medical devices – Information to be provided
by manufacture for the processing of resterilizable medical devices
40.ISO/DIS 17665; 2004, Sterilization of health care products – Moist heat –
Development, Validation and routine control of a sterilization process for
medical devices
41.ISO 14708-1;2000, Implants for surgery – Active Implantable medical devices
– Part 1: General requirements for safety, marking and for information to
be provided by the manufacturer
42.ISO-14708-5: 2005,Implants for surgery – Active implantable medical devices
– Part 5: Particular requirements for circulatory support devices (2005)
43.ISO 5198, Centrifugal, mixed flow axial flow pumps –
performance tests –
Code for hydraulic
Precision grade
44.ISO 4409, Hydraulic fluid power – Positive displacement pumps, motos and
integral transmissions –
Determination of steady-state performance
45.ISO 5840, Cardiovascular implants –
Cardiac valve prostheses
46.ISO 7198, Cardiovascular implants –
Tubular vascular prostheses
（IEC）
1.IEC 60300-3-2, Dependability management – Part 3 – 2: Application guide
– Collection of essential performance
2.IEC 60601-1, Medical electrical equipment – Part 1: General requirement for
safety and essential performance
3.IEC 60601-1-2, Medical electrical equipment – Part 1: General requirement
for safety – Collateral standard: Electromagnetic compatibility –
Requirements and tests
4.IEC 60601-1-6, Medical electrical equipment - Part 1; General requirement
for safety –
Collateral standard: Usability
5.IEC 60601-1-8, Medical electrical equipment –
requirement for safety –
6.IEC –
Part 1 –
8: General
Collateral Standard: Alarms
CISPR-11, Industrial scientific and medical (ISM) radio-frequency
18
40 / 41
materials of animal origin – Validation and routine control of sterilization
by liquid sterilants
38.ISO 14937, 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
39.ISO 17664, Sterilization of medical devices – Information to be provided
by manufacture for the processing of resterilizable medical devices
40.ISO/DIS 17665; 2004, Sterilization of health care products – Moist heat –
Development, Validation and routine control of a sterilization process for
medical devices
41.ISO 14708-1;2000, Implants for surgery – Active Implantable medical devices
– Part 1: General requirements for safety, marking and for information to
be provided by the manufacturer
42.ISO-14708-5: 2005,Implants for surgery – Active implantable medical devices
– Part 5: Particular requirements for circulatory support devices (2005)
43.ISO 5198, Centrifugal, mixed flow axial flow pumps –
performance tests –
Code for hydraulic
Precision grade
44.ISO 4409, Hydraulic fluid power – Positive displacement pumps, motos and
integral transmissions –
Determination of steady-state performance
45.ISO 5840, Cardiovascular implants –
Cardiac valve prostheses
46.ISO 7198, Cardiovascular implants –
Tubular vascular prostheses
（IEC）
1.IEC 60300-3-2, Dependability management – Part 3 – 2: Application guide
– Collection of essential performance
2.IEC 60601-1, Medical electrical equipment – Part 1: General requirement for
safety and essential performance
3.IEC 60601-1-2, Medical electrical equipment – Part 1: General requirement
for safety – Collateral standard: Electromagnetic compatibility –
Requirements and tests
4.IEC 60601-1-6, Medical electrical equipment - Part 1; General requirement
for safety –
Collateral standard: Usability
5.IEC 60601-1-8, Medical electrical equipment –
requirement for safety –
6.IEC –
Part 1 –
8: General
Collateral Standard: Alarms
CISPR-11, Industrial scientific and medical (ISM) radio-frequency
18
40 / 41