BS EN 285 has been revised to reference the relationship between the standard and Directive 93/42/EEC on medical devices. The Relevant Essential Health and Safety Requirements from Directive 2006/42/EC on machinery are also addressed by the revised version of BS EN 285.
BS EN 285 is an amended standard that specifies the 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 BS EN 285 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 sterilizer 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.
Large steam sterilizers can also be used during the commercial production of medical devices.
BS EN 285 is not applicable to steam sterilizers designed to process a size of load less than one sterilization module or having a chamber volume less than 60 l.
BS EN 285 does not describe a quality assurance system for the control of all stages of the manufacture of the sterilizer.
Attention is drawn to the standards for quality management systems e.g. BS EN ISO 13485.
Environmental impact of product
BS EN 285 addresses the environmental aspects of steam sterilisers. Planning and design of products applying to this European Standard should consider the environmental impact from the product during its life cycle. Additional aspects of environmental impact are addressed in BS EN ISO 14971, the international Standard that covers risk management for medical devices.
Contents of BS EN 285 include:
- Scope
- Normative references
- Terms and definitions
- Mechanical components
- Process components
- Instrumentation, indicating and recording devices
- Control systems
- Performance requirements
- Sound power
- Rate of pressure change
- Safety
- Marking
- Service and local environment
- Testing
- Hollow load test
- Thermometric tests
- Bowie and Dick test
- Air leakage test
- Air detector tests
- Load dryness tests
- Sound power test
- Steam quality tests
- Dynamic sterilizer chamber pressure test
- Test apparatus, equipment and material
- Documentation to be supplied by the manufacturer
- Information to be supplied by the manufacturer
- Environmental aspects
- Steam supply; suggested maximum values of contaminants in feed water and condensate
- Recommended materials
- Temperature and time tolerances during the small load thermometric test
- Guidance for installation and operational qualification tests to be included in the instructions for use supplied with a sterilizer
- Criteria for identifying sterilizers as the same type
- Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices
- Bibliography
