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 (38 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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improvements.
4.ISO 10993 – 1: 2003
Biological evaluation of medical devices – Part 1:
Evaluation and testing
5.ISO 10993 –
2: 1998, Biological evaluation of medical devices –
Part
2:Animal welfare requirements
6.ISO 10993 – 3: 2003, Biological evaluation of medical devices – Part 3:
Tests for genotoxicity, carcinogenicity, and reproductive toxicity
7.ISO 10993 – 4: 2002, Biological evaluation of medical devices – Part 4:
Selection of tests for interaction with blood
8.ISO 10993 – 5: 1999, Biological evaluation of medical devices – Part 5:
Tests for in vitro cytotoxicity
9.ISO 10993 – 6: 1994, Biological evaluation of medical devices – Part 6:
Tests for local effects after implantation
10.ISO 10993 – 7: 1996, Biological evaluation of medical devices – Part 7:
Ethylene oxide sterilization residuals
11.ISO 10993 – 9: 1999, Biological evaluation of medical devices –
Part 9:
Framework for identification and quantification of potential degradation
products
12.ISO 10993 – 10: 2002, Biological evaluation of medical devices – Part 10:
Tests for irritation and delayed –
type hypersensitivity
13.ISO 10993: 11: 1996, Biological evaluation of medical devices – Part 11:
Tests for systemic toxicity
14.ISO 10993 – 12: 1996, Biological evaluation of medical devices – Part 12:
Sample preparation and reference materials
15.ISO 10993: - 13: 1998, Biological evaluation of medical devices – Part 13:
Identification and quantification of degradation products from polymeric
materials
16.ISO
10993 – 14: 2004, Biological evaluation of medical devices – Part 14:
Identification and quantification of degradation from products from
ceramics.
17.ISO 10993 – 15: 2000, Biological evaluation of medical devices – Part 15:
Identification and quantification of degradation products from metals and
alloys
18.ISO 10993 – 16: 1997, Biological evaluation of medical devices – Part 16,
Toxicokinetic study design for degradation products and leachables.
19.ISO 10993 – 17: 2003, Biological evaluation of medical devices – Part 17,
16
38 / 41
4.ISO 10993 – 1: 2003
Biological evaluation of medical devices – Part 1:
Evaluation and testing
5.ISO 10993 –
2: 1998, Biological evaluation of medical devices –
Part
2:Animal welfare requirements
6.ISO 10993 – 3: 2003, Biological evaluation of medical devices – Part 3:
Tests for genotoxicity, carcinogenicity, and reproductive toxicity
7.ISO 10993 – 4: 2002, Biological evaluation of medical devices – Part 4:
Selection of tests for interaction with blood
8.ISO 10993 – 5: 1999, Biological evaluation of medical devices – Part 5:
Tests for in vitro cytotoxicity
9.ISO 10993 – 6: 1994, Biological evaluation of medical devices – Part 6:
Tests for local effects after implantation
10.ISO 10993 – 7: 1996, Biological evaluation of medical devices – Part 7:
Ethylene oxide sterilization residuals
11.ISO 10993 – 9: 1999, Biological evaluation of medical devices –
Part 9:
Framework for identification and quantification of potential degradation
products
12.ISO 10993 – 10: 2002, Biological evaluation of medical devices – Part 10:
Tests for irritation and delayed –
type hypersensitivity
13.ISO 10993: 11: 1996, Biological evaluation of medical devices – Part 11:
Tests for systemic toxicity
14.ISO 10993 – 12: 1996, Biological evaluation of medical devices – Part 12:
Sample preparation and reference materials
15.ISO 10993: - 13: 1998, Biological evaluation of medical devices – Part 13:
Identification and quantification of degradation products from polymeric
materials
16.ISO
10993 – 14: 2004, Biological evaluation of medical devices – Part 14:
Identification and quantification of degradation from products from
ceramics.
17.ISO 10993 – 15: 2000, Biological evaluation of medical devices – Part 15:
Identification and quantification of degradation products from metals and
alloys
18.ISO 10993 – 16: 1997, Biological evaluation of medical devices – Part 16,
Toxicokinetic study design for degradation products and leachables.
19.ISO 10993 – 17: 2003, Biological evaluation of medical devices – Part 17,
16
38 / 41