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EFHSS Questions and Answers - Question Q00583

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EFHSS - Questions & Answers - Steam Sterilization - Q00583
Any (EN-55??) Standard or guidelines for reference

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From: (India) Date: 26 August 2004, 06:22 [GMT]
Subject: Any (EN-55??) Standard or guidelines for reference

Please let me know any guideline available for the steam sterilization. Specifically any EN-554 or etc.

We are supposed to supply the PC based automation for the steam
sterilizer and hence want to have enough knowledge on subject before developing the process automation software.

Thanks and regards.

From: (Belgium) Date: 26 August 2004, 13:07 [GMT]
Subject: Re: Any (EN-55??) Standard or guidelines for reference

Here a list of european standards and...

for definitions:
EN 556, ISO 14937, EN 980
for quality systems:
EN ISO 724, EN ISO 9000:1994/7, EN ISO 9000:2000, EN ISO 9001:1994, EN ISO 9002:1994, EN ISO 13485:2001, EN ISO 13485:2003, EN ISO 13488:2001, EN 45012:1998, EN 46002:1997, EN 46003:1999
for equipment:
EN 285, EN 562, EN 1422, pr EN 13060, pr EN15883, ISO 14160, EN 14180
for validation:
EN 554, EN 550, EN ISO 13824
for monitoring:
EN 866, EN 867, EN ISO 10993, EN ISO 11737, EN 1174, EN ISO 14161
for information:
pr EN 17664
for packaging:
EN 868
for drapes:
pr EN 13795

Look at directives 1993/42/EC, 2001/95/EC

Also look at CEN standards at www.cenorm.be

and http://europa.eu.int/comm/consumers/cons_safe/prod_safe/gpsd/currentGPSD_en.htm.

send me your mail address and I will reply with a power point presentation about sterility norms in general, their history and how these commissions work....

see you
jef
--
Email:

From: (uk) Date: 12 May 2005, 17:28 [GMT]
Subject: Re: Any (EN-55??) Standard or guidelines for reference

Please can you advise when EN 15883 will be coming into force?

Will there be a norm that covers ultrasonic systems (desgin and validation)

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