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NederlandseOntwerpnormNENENISO 117371Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products (ISO/DIS 117371:2004,IDT)Publicatie.

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ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package.

ISO 11737-1:2006 specifies requirements and provides guidance for the enumeration and microbial characterization of the population of viable micro-organisms on or in a medical device, component, raw material or package.

Bioburden testing for terminally sterilized medical devices is performed ing to ISO 11737-1. Bioburden testing is primarily performed by cutting up, disassembling, or flushing the fluid path of the test unit using sterile tools to prepare the sample.

Bioburden testing by ISO 11737-1, aerobic bacteria and fungi This analysis follows the ISO 11737-1 standard and detects populations of viable microorganisms on a product before sterilization, thus indicating the microbiological cleanliness of the product.

ISO 11135 is the international standard that details the development and validation of a process for sterilizing medical devices using ethylene oxide. Ethylene oxide has been used for sterilization since the 1940s.

Specifies general criteria to be applied in the estimation of the population of viable microorganisms on a medical device or component, raw material or device packaging.

Depending on the product bioburden this range can be from 15 kGy to 35 kGy.

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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Content Takedown Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232