PRICES include / exclude VAT
Sponsored link
immediate downloadReleased: 2006-11-30
BS EN 556-1:2001
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" Part 1. Requirements for terminally sterilized medical devices
Format
Availability
Price and currency
English Secure PDF
Immediate download
163.80 USD
English Hardcopy
In stock
163.80 USD
Standard number: | BS EN 556-1:2001 |
Pages: | 12 |
Released: | 2006-11-30 |
ISBN: | 0 580 38311 3 |
Status: | Corrigendum |
DESCRIPTION
BS EN 556-1:2001
This standard BS EN 556-1:2001 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" is classified in these ICS categories:
- 11.080.01 Sterilization and disinfection in general
This European Standard specifies the requirements for a terminally-sterilized medical device to be designated "STERILE". Part 2 of this European Standard specifies the requirements for an aseptically processed medical device to be designated "STERILE".
NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designation of a medical device as "STERILE" is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN 550 , EN 552 , EN 554 , EN ISO 14160 and EN ISO 14937.
Customers who bought this item also bought
BS EN 455-4:2009
Medical gloves for single use Requirements and testing for shelf life determination
Medical gloves for single use Requirements and testing for shelf life determination
Released: 2009-08-31
English Secure PDF
Immediate download
195.00 USD
English Hardcopy
In stock
195.00 USD
English Secure PDF
Immediate download
317.20 USD
English Hardcopy
In stock
317.20 USD
BS EN 14683:2019
Medical face masks. Requirements and test methods
Medical face masks. Requirements and test methods
Released: 2019-08-22
English Secure PDF
Immediate download
270.40 USD
English Hardcopy
In stock
270.40 USD
BS EN 149:2001+A1:2009
Respiratory protective devices. Filtering half masks to protect against particles. Requirements, testing, marking
Respiratory protective devices. Filtering half masks to protect against particles. Requirements, testing, marking
Released: 2009-07-31
English Secure PDF
Immediate download
317.20 USD
English Hardcopy
In stock
317.20 USD