ISO 11137-3:2017
ISO · 2017-06
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
1Key Takeaways
This document gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in radiation sterilization process.
2Scope / Description
This document gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in radiation sterilization process.
3Version History
ISO 11137-3:2017
2017-06
5Citation Network
8
Cite this standard
28
Referenced herein
Standards that cite ISO 11137-3:2017
Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
Sterile drainage catheters and accessory devices for single use
Sterilization of health care products — Radiation — Part 4: Guidance on process control
Guidelines for Process Control of Radiation Sterilization of Health Care Products
Radiation sterilization of medical devices Part 4: Guidance on process control
Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020)
Referenced by ISO 11137-3:2017
AAMI/TIR 29
ASTM E2232-16
G
ISO 10012:2003
ISO 11137-1:2006
ISO 11137-2:2013
ISO 11462-2:2010
ISO 13485:2016
6Frequently Asked Questions
What is ISO 11137-3:2017?
ISO 11137-3:2017 — Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control is an international standard developed by International Organization for Standardization (ISO). This document gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in radiation sterilization process.
What does ISO 11137-3:2017 cover?
This standard covers: This document gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in radiation sterilization process.
Who should use this standard?
This standard is intended for organizations, professionals, and stakeholders involved in various industries and sectors. It is applicable to manufacturers, service providers, regulatory bodies, and certification organizations.
What is the latest version of ISO 11137-3:2017?
The current published version is ISO 11137-3:2017, published on 2017-06. Always check for amendments or pending revisions.
How do I purchase ISO 11137-3:2017?
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