ГОСТ Р 57623-2017/EN 1422:2014. Национальный стандарт Российской Федерации. Стерилизаторы для медицинских целей. Стерилизаторы на основе этиленоксида. Требования и методы испытаний

EN 285:2006+A2:2009

Sterilization - Steam sterilizers - Large sterilizers

EN 867-5:2001

Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S

EN 1041

Information supplied by the manufacturer of medical devices

EN 1837

Safety of machinery - Integral lighting of machines

EN 60204-1:2006

Safety of machinery - Electrical equipment of machines - Part 1: General requirements (IEC 60204-1:2005, modified)

EN 61508-1:2010

Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements

EN 62061:2005

Safety of machinery - Functional safety of safety-related electrical, electronic and programmable electronic control systems

EN 62304:2006

Medical device software - Software life-cycle processes (IEC 62304:2006)

EN ISO 9000:2005

Quality management systems - Fundamentals and vocabulary

EN ISO 9001:2008

Quality management systems - Requirements (ISO 9001:2008)

EN ISO 11203:2009

Acoustics - Noise emitted by machinery and equipment - Determination of emission sound pressure levels at a work station and at other specified positions from the sound power level

EN ISO 12100:2010

Safety of machinery - General principles for design - Risk assessment and risk reduction

EN ISO 13485:2012

Medical devices - Quality management systems - Requirements for regulatory purposes

EN ISO 14937:2009

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical

EN 60073:2002

Basic and safety principles for man-machine interface, marking and identification - Coding principles for indicators and actuators

ИСО/ТС 11139:2006

Sterilization of health care products - Vocabulary

[1]

ANSI/AAMIST41

Ethylene oxide sterilization in health care facilities: Safety and effectiveness

[2]

Directive 94/9/EC of the European Parliament and the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres (ATEX)

[3]

Directive 97/23/EEC of the European Parliament and of the Council of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment

[4]

Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC (EMC)

[5]

Directive 2006/95/EC of the European Parliament and of the Council of 12 December 2006 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (LVD)

[6]

EO Product Stewardship Manual, 3rd Edition, American Chemistry Council, May 2007

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LINE S.J., PICKERILL J.K. J Clin. Pathol. 1973, 26 pp. 716 - 720

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MOLNARNE S. Schendler: Safety Characteristic Data, Volume 2, Explosion Regions of Gas Mixtures, NW-Verlag, Bremerhaven, 2008

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NYQUIST H. Certain Topics in Telegraph Transmission Theory, Transactions of the AIEE, 1928; 47:617-44

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Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (REACH)

[11]

Technical Regulations for hazardous substances TRGS 513, Activities on sterilizers with ethylene oxide and formaldehyde, published by German Federal Institute for Materials Research and Testing (BAM), 2011