PRICES include / exclude VAT
Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.080 Sterilization and disinfection>11.080.10 Sterilizing equipment>BS EN 285:2015+A1:2021 Sterilization. Steam sterilizers. Large sterilizers
Sponsored link
immediate downloadReleased: 2021-11-09
BS EN 285:2015+A1:2021 Sterilization. Steam sterilizers. Large sterilizers

BS EN 285:2015+A1:2021

Sterilization. Steam sterilizers. Large sterilizers

Format
Availability
Price and currency
English Secure PDF
Immediate download
438.78 USD
English Hardcopy
In stock
438.78 USD
Standard number:BS EN 285:2015+A1:2021
Pages:144
Released:2021-11-09
ISBN:978 0 539 01380 1
Status:Standard
DESCRIPTION

BS EN 285:2015+A1:2021


This standard BS EN 285:2015+A1:2021 Sterilization. Steam sterilizers. Large sterilizers is classified in these ICS categories:
  • 11.080.10 Sterilizing equipment
This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads. This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l. Large steam sterilizers can also be used during the commercial production of medical devices. This European Standard does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process biological waste or human tissues. This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer. NOTE 1 Attention is drawn to the standards for quality management systems e.g. EN ISO 13485. NOTE 2 Environmental aspects are addressed in Annex A.