よむ、つかう、まなぶ。
【資料１】次世代医療機器評価指標について (39 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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Methods for the establishment of allowable limits for leachable substances.
20.ISO 10993 – 18: 2004, Biological evaluation of medical devices – Part 18:
Chemical characterization of materials.
21.ISO 10993 –
19：2005, Physico-chemical, morphological and topographical
characterization of materials.
22.ISO TS 10993 – 20: 2003, Biological evaluation of medical devices – Part
20: Principles and methods for immunotoxicology testing of medical devices
23.ISO 14415-1, Clinical investigation of medical devices for human subjects
–
Part 1: General requirements
24.ISO 14415-2. Clinical investigation of medical devices for human subjects
–
25.ISO
Part 2: Clinical investigation plants
13485:2003,
Medical
devices
–
Quality
management
Medical
devices
systems
–
Requirements for regulatory purposes.
26.ISO
13448:1996,
Quality
systems
–
–
Particular
requirements for the application of ISO 9002.
27.ISO 14971: 2000, Medical Devices – Application of risk management to medical
devices.
28.ISO/DIS 22442-1 Application of risk management, Medical devices utilizing
animal tissues and their derivatives
29.ISO/DIS 22442-2 Control on sourcing, collection and handling, Medical
devices utilizing animal tissues and their derivatives
30.ISO/DIS22442-3 Validation of the elimination and / or inactivation of viruses
and transmissible spongiform encephalopathy (TSE) agents, Medical devices
utilizing animal tissues and their derivatives
31.ISO 11134 Sterilization of health care products-Requirements for validation
and routine control –
industrial moist heat sterilization
32.ISO 11135:1994 Medical devices; validation and routine control of ethylene
oxide sterilization
33.ISO 11137; 1995, Sterilization of health care products – Requirements for
validation and routine control - Radiation sterilization
34.ISO 11737-1; 1995, Sterilization of medical devices- Microbiological methods
–
Part 1; Estimation of population of microorganisms on products
35.ISO 13408 series, Aseptic proceeding of health care products
36.ISO 13638; 1997, Sterilization of health care products – Requirements for
Validation and routine control of moist heat sterilization in health care
facilities
17
39 / 41
20.ISO 10993 – 18: 2004, Biological evaluation of medical devices – Part 18:
Chemical characterization of materials.
21.ISO 10993 –
19：2005, Physico-chemical, morphological and topographical
characterization of materials.
22.ISO TS 10993 – 20: 2003, Biological evaluation of medical devices – Part
20: Principles and methods for immunotoxicology testing of medical devices
23.ISO 14415-1, Clinical investigation of medical devices for human subjects
–
Part 1: General requirements
24.ISO 14415-2. Clinical investigation of medical devices for human subjects
–
25.ISO
Part 2: Clinical investigation plants
13485:2003,
Medical
devices
–
Quality
management
Medical
devices
systems
–
Requirements for regulatory purposes.
26.ISO
13448:1996,
Quality
systems
–
–
Particular
requirements for the application of ISO 9002.
27.ISO 14971: 2000, Medical Devices – Application of risk management to medical
devices.
28.ISO/DIS 22442-1 Application of risk management, Medical devices utilizing
animal tissues and their derivatives
29.ISO/DIS 22442-2 Control on sourcing, collection and handling, Medical
devices utilizing animal tissues and their derivatives
30.ISO/DIS22442-3 Validation of the elimination and / or inactivation of viruses
and transmissible spongiform encephalopathy (TSE) agents, Medical devices
utilizing animal tissues and their derivatives
31.ISO 11134 Sterilization of health care products-Requirements for validation
and routine control –
industrial moist heat sterilization
32.ISO 11135:1994 Medical devices; validation and routine control of ethylene
oxide sterilization
33.ISO 11137; 1995, Sterilization of health care products – Requirements for
validation and routine control - Radiation sterilization
34.ISO 11737-1; 1995, Sterilization of medical devices- Microbiological methods
–
Part 1; Estimation of population of microorganisms on products
35.ISO 13408 series, Aseptic proceeding of health care products
36.ISO 13638; 1997, Sterilization of health care products – Requirements for
Validation and routine control of moist heat sterilization in health care
facilities
17
39 / 41