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BS ISO 15198:2004

Действует
Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer — 18 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

BS ISO 3534-1:2006
Действует
Statistics. Vocabulary and symbols. General statistical terms and terms used in probability — 116 стр.
ISO 5725-1:1994
Действует
Accuracy (trueness and precision) of measurement methods and results. Part 1. General principles and definitions — 24 стр.
ISO 13485:2003
Заменен
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 стр.
ISO 9001:2015
Действует
Quality management systems -- Requirements — 40 стр.
ISO 10005:2018
Действует
Quality management -- Guidelines for quality plans — 36 стр.
ISO 15194:2009
Действует
In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Requirements for certified reference materials and the content of supporting documentation — 24 стр.
ISO/IEC Guide 51:2014
Действует
Safety aspects -- Guidelines for their inclusion in standards — 22 стр.
BS EN 3759:1997
Действует
Screws, pan head, offset cruciform recess, threaded to head, in heat and corrosion resisting steel, passivated. Classification: 1100 MPa (at ambient temperature)/425$0DC — 14 стр.
BS EN 591:2001
Заменен
Instructions for use for in vitro diagnostic instruments for professional use — 14 стр.
BS EN 1041:1998
Заменен
Information supplied by the manufacturer with medical devices — 20 стр.

На этот документ ссылаются

BS EN ISO 18113-1:2009
Заменен
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Terms, definitions and general requirements — 60 стр.
BS EN ISO 14971:2009
Заменен
Medical devices. Application of risk management to medical devices — 96 стр.
BS EN 2436-006:2006
Действует
Aerospace series. Paints and varnishes. Corrosion resistant chromate-free two component cold curing epoxy primer. High corrosion resistance for military application — 18 стр.
BS EN 2435-005:2006
Действует
Aerospace series. Paints and varnishes. Corrosion resistant chromated two component cold curing primer. High corrosion resistance for military application — 18 стр.
BS EN 2434-005:2006
Действует
Aerospace series. Paints and varnishes. Two component cold curing polyurethane finish. High flexibility and chemical agent resistance for military application — 20 стр.
BS EN ISO 3248:2016
Действует
Paints and varnishes. Determination of the effect of heat — 12 стр.
BS EN 13523-7:2014
Действует
Coil coated metals. Test methods. Resistance to cracking on bending (T-bend test) — 20 стр.
BS EN 1396:2015
Действует
Aluminium and aluminium alloys. Coil coated sheet and strip for general applications. Specifications — 36 стр.
BS ISO 17593:2007
Действует
Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy — 64 стр.
PD ISO/TS 16688:2017
Действует
Guidelines for the selection of coating types, tests and methods of assessing the performance of coated aluminium in architectural applications — 44 стр.
BS EN ISO 14971:2012
Действует
Medical devices. Application of risk management to medical devices — 104 стр.
DIN EN ISO 18113-1:2013-01
Действует
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011 — 60 стр.
DIN EN ISO 18113-1:2010-05
Отменен
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2009 — 62 стр.