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Items: 1 to 20 of 116

1.

[Preliminary discussion on the preparation of medical device standards].

Zheng J, Yu X.

Zhongguo Yi Liao Qi Xie Za Zhi. 2012 Nov;36(6):444-6. Chinese.

PMID:
23461124
2.

[Preliminary discussion on the preparation of medical device standards adopting international standards].

Zheng J, Yu X.

Zhongguo Yi Liao Qi Xie Za Zhi. 2012 May;36(3):215-7. Chinese.

PMID:
22916484
3.

[Investigation on Medical Device Standards].

Li J.

Zhongguo Yi Liao Qi Xie Za Zhi. 2009 Sep;33(5):362-8. Chinese.

PMID:
20073246
4.

Update on ISO 13485.

Donawa M.

Med Device Technol. 2002 Mar;13(2):23-5.

PMID:
11984989
5.

[Discussion on control method of testing standards for medical device test lab].

Yu P.

Zhongguo Yi Liao Qi Xie Za Zhi. 2012 Jul;36(4):296-8. Chinese.

PMID:
23189650
6.

[Standards used in the regulation of medical device in USA].

Hu W, Gu H.

Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2007 Nov;21(11):1263-7. Chinese.

PMID:
18069490
7.

Achieving systematic compliance with the Medical Device Directive.

Lally R.

Med Device Technol. 1996 Sep;7(7):28-33.

PMID:
10172791
8.

[Discussion on the revision of National Administrative Provisions for the Sampling and Testing of Quality Supervision on Medical Devices].

Hao Q, Shi X, Zhang X, Zhu J.

Zhongguo Yi Liao Qi Xie Za Zhi. 2013 Sep;37(5):373-5, 378. Chinese.

PMID:
24409801
9.

[Research of the transformation and implementation of IEC60601-1 3rd edition in China].

Zheng J, Zhang C, Yu X.

Zhongguo Yi Liao Qi Xie Za Zhi. 2011 Jul;35(4):284-5. Chinese.

PMID:
22097755
10.

The impact of the new quality management system standards on the CE-marking process.

Donawa M.

Med Device Technol. 2001 Jan-Feb;12(1):34-9.

PMID:
11317864
11.

[Review and experience on inter-laboratory comparisons of medical device testing].

Wang D, Liang HF.

Zhongguo Yi Liao Qi Xie Za Zhi. 2011 Jul;35(4):286-7. Chinese.

PMID:
22097756
12.

[Exploration on the regulation mode of medical device quality and safety on a life-circle basis].

Yu HL, Qian XS.

Zhongguo Yi Liao Qi Xie Za Zhi. 2006 Mar;30(2):120-2, 133. Chinese.

PMID:
16830806
13.

[The current situation and consideration on the quality of medical device standards in China].

Yang X, Mu Rh, Li J.

Zhongguo Yi Liao Qi Xie Za Zhi. 2014 Sep;38(5):383-5. Chinese.

PMID:
25597093
14.

ISO 9000:2000 revisions and their implications.

Sim P.

Med Device Technol. 2000 May;11(4):45-7.

PMID:
11010320
15.

[Development of standardization and certification of the quality of medical devices].

Gundarov VP, Kavalerov GI.

Med Tekh. 2001 May-Jun;(3):4-8. Russian.

PMID:
11515269
16.

The total quality assurance system in the medical device industry (under the guidance of the medical device directives).

Panteloglou A.

Perit Dial Int. 1993;13 Suppl 2:S573-5. No abstract available.

PMID:
8399668
17.

[Analysis on the main difference and impact between IEC 60601-1 in Ed. 3.1 and GB 9706.1-2007].

Zheng J, He J, Yu X.

Zhongguo Yi Liao Qi Xie Za Zhi. 2014 Nov;38(6):442-4. Chinese.

PMID:
25980136
18.

Rationalization of standards for medical devices--Part 2.

Riordan JJ.

Med Instrum. 1975 Jul-Aug;9(4):197-201.

PMID:
1143124
19.

Effectively incorporating risk management into quality systems.

Donawa M.

Med Device Technol. 2006 Jun;17(5):28-30.

PMID:
16903387
20.

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