EFHSS  European Forum for Hospital Sterile Supply

EFHSS Questions and Answers - Answer to Question Q00583

Categories Authors Questions Unanswered Questions Questions with Answers Questions and Answers Submit New Question Help

Category Sort By Sort Order
View

Please fill out the following form and submit it to post a reply and/or answer to question Q00583 to the EFHSS Questions and Answers pages. For new questions please use the Submit New Question form instead.

EFHSS Questions and Answers - Answer to Question Q00583
Your Details:
Name:
Email:
Country:
Your answer/reply:
Message:
 

Please contact/notify if you have any questions and/or problems using the EFHSS Questions and Answers pages.

EFHSS - Questions & Answers - Steam Sterilization - Q00583
Any (EN-55??) Standard or guidelines for reference 		Follow Up
Web Search
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:

EFHSS  European Forum for Hospital Sterile Supply

Developed by Baumeister Mediasoft Engineering