ГОСТ Р ЕН 13641-2010 Устранение или снижение риска инфицирования, связанного с реагентами для диагностики in vitro

EН 12442-1

Ткани животных и их производные, используемые при изготовлении медицинских изделий. Часть 1. Анализ и менеджмент риска (Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk)

EН 12442-2

Ткани животных и их производные, используемые при изготовлении медицинских изделий. Часть 2. Контроль источников, сбора и обработки. (Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2: Controls on sourcing, collection and handling)

EН 12442-3

Ткани животных и их производные, используемые при изготовлении медицинских изделий. Часть 3. Подтверждение устранения и/или инактивации вирусов и трансмиссивных агентов. Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents

[1]

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, OJEC, 1998, No L 331

[2]

Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the member states relating to personal protective equipment

[3]

Council Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work (seventh individual Directive within the meaning of article 16 (1) of Directive 89/391/EEC) and Council Directive 93/88/EEC of 12 October 1993 amending Directive 90/679/EEC on the protection of workers from risks related to exposure to biological agents at work (seventh individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC) amended by Directives 93/88/EEC of 12 October 1993, 95/30/EC of 30 June 1995, 97/59/EC of 7 October 1997 and 97/65/EC of 26 November 1997

[4]

Protection of Laboratory Workers from Instrument Biohazards and Infectious Diseases Transmitted by Blood, Body Fluids and Tissue; Approved Guideline; NCCLS Doc. M29-A Vol.17, N 20 (1997)

[5]

Laboratory Biosafety Manual (2nd Edition) WHO (1993)

[6]

Laboratory Safety Principles and Practices (2nd Edition) Ed. Fleming D.O., Richardson J.H., Tulis J.J., Vesley D.; ASM (American Society of Microbiology) Press, Washington (USA) (1995)

[7]

Clinical Laboratory Safety: Approved Guideline; NCCLS Doc. GP17-A Vol.16 No. 6 (1996)

[8]

Guidelines for Prevention of Transmission of Human Immunodeficiency Virus and Hepatitis B Virus to Health-Care and Public-Safety Workers; CDC Prevention Guidelines MMWR Vol.38, No 5-6 (1989)

[9]

Clinical Laboratory Waste Management; Approved Guideline; NCCLS Doc. GP5-A Vol.13 No. 22 (1993)

[10]

UN Recommendations on the Transport of Dangerous Goods - ST/SG/AC.10/1/Rev. 8, United Nations, New York and Geneva, 1995

[11]

Guideline for the Safe Transport of Infectious Substances and Diagnostic Specimens, WHO, 1997