Your cart is currently empty!
“ISO 11737:2021 Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products – Amendment 1” has been added to your cart. View cart
ISO 11737:2023
ISO 11737:2023 Sterilization of health care products – Microbiological methods – Part 3: Bacterial endotoxin testing
CDN $351.00
Description
This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in health care products, components or raw materials using bacterial endotoxins test (BET) methods, using amebocyte lysate reagents. This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins. Other endotoxin detection methodologies are not included (see B.12). This document does not address setting specific endotoxin limit specifications.
Edition
1
Published Date
2023-06-26
Status
PUBLISHED
Pages
62
Language
English
Format
Secure PDF
Secure – PDF details
- Save your file locally or view it via a web viewer
- Viewing permissions are restricted exclusively to the purchaser
- Device limits - 3
- Printing – Enabled only to print (1) copy
See more about our Environmental Commitment
Abstract
This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in health care products, components or raw materials using bacterial endotoxins test (BET) methods, using amebocyte lysate reagents. This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins. Other endotoxin detection methodologies are not included (see B.12). This document does not address setting specific endotoxin limit specifications.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 17665:2024 Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices
CDN $390.00 Add to cart -
ISO 11737:2021 Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products – Amendment 1
CDN $32.00 Add to cart -
ISO 11139:2024 Sterilization of health care products – Vocabulary of terms used in sterilization and related equipment and process standards – Amendment 1: Amended and additional terms and definitions
CDN $32.00 Add to cart -
ISO 20520:2018 Traditional Chinese medicine – Infection control for acupuncture treatment
CDN $76.00 Add to cart
