Legislation and Standards we comply with:
EU legislation we comply with
The Medical Devices Directive
Council Directive 93/42/EEC concerning medical devices as amended.
UK LEGISLATION WE COMPLY WITH
The Pressure Systems Safety Regulations 2000
Requiring pressure systems to be inspected in order to improve safety.
Standards we comply with
BS EN ISO 14971
Medical devices – Application of risk management to medical devices.BS EN 1041
Information supplied by the manufacturer of medical devices.BS EN 13060
Small steam sterilisers.BS EN 61010-1
Safety requirements for electrical equipment for measurement, control and laboratory use – Part 1: General requirementsBS EN 61000-3-3
Electromagnetic compatibility (EMC) – Part 3: Limits – Section 3: Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current less than or equal to 16 A per phase and not subject to conditional connection.ISO 13485
Medical devices - Quality management systems - Requirements for regulatory purposesBS EN 62366
Medical devices - Application of usability engineering to medical devicesEN 61010-2-040
Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-040: Particular requirements for sterilisers and washer-disinfectors used to treat medical materialsEN 61326-1
Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 1: General RequirementsBS EN 62304
Medical device software - Software life-cycle processesBS EN ISO 15223-1
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirementsQuality Assurance
5 Year Guarantee
We provide an unbeatable 5 year parts guarantee. For more information please click here.
Made in the U.K
Our sterilisers are manufactured with care in the United Kingdom.
CE
This symbol confirms that the Acuatic Vacuum steriliser complies with Council Directive 93/42/EEC concerning medical devices as amended.
ISO 13485
ISO 13485 is an international standard that specifies a quality management system specifically targeted toward the medical device world. It incorporates a risk management approach to product development. Our compliance with ISO 13485 ensures our ability to supply quality sterilisers that consistently meet customer and regulatory requirements.
Notified Body
The Notified Body used to check our compliance with the Medical Devices Directive is BSI. Click here to view our Quality Assurance certificate.