Schedule of Accreditation issued by United Kingdom Accreditation Service High Street, Feltham, Middlesex, TW13 4UN, UK

Transcription

1 21-47 High Street, Feltham, Middlesex, TW13 4UN, UK ISO/IEC 17025:2005 Wonersh House The Guildway Old Portsmouth Road Guildford Surrey GU3 1LR Contact: Mr K Harland Tel: +44 (0) Fax: +44 (0) karl.harland@uk.ul.com Website: Testing performed at the above address only DETAIL OF ACCREDITATION SECTION 1: AUDIO, VIDEO AND SIMILAR ELECTRONIC APPARATUS Audio, video and similar electronic apparatus Electrical safety BS EN 60065:2002 IEC 60065:2001 Clause 6.2, Laser radiation Clause 7, Softening Temperature Clause 10.1, Surge Clause , Vibration Clause 14.1, Resistors Clause 14.2, Capacitors and RC units Clause 14.6, Switches Clause 16, External flexible cords Clause 18, Mechanical strength Clause Preconditioning of circuit boards SECTION 2: ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE Safety requirements for electrical for measurement, control and laboratory use Electrical safety BS EN :2001, Corrig 1 and 2 IEC :2001, Corrig 1 and 2 Clause 11.6, Specially protected Clause 12.3, UV radiation Clause 12.4, Microwave radiation Assessment Manager: CG1 Page 1 of 5

2 SECTION 2: ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE Safety requirements for electrical for measurement, control and laboratory use Electrical safety Clause , Ultrasonic pressure Clause 12.6, Laser sources Clause 13.3, Implosion of CRT s Clause 14.9, Components - general BS EN :1993, Amd 1 IEC :1990, Amds 1 and 2 Clause 10.3, Resistance to heat Clause 11.6, Specially protected Clause 12.3, UV radiation Clause 12.4, Microwave radiation Clause , Ultrasonic pressure Clause 12.6, Laser sources Clause 13.3, Implosion of CRT's Clause 14.1, Components - general SECTION 3: MEDICAL ELECTRICAL EQUIPMENT Medical electrical Electrical safety BS EN : 2006 IEC : 2005 Clause 6.4, Sterilization Clause , Rubber ageing only Clause 10, Clauses 11.4, Ignition of flammable anaesthetic mixtures Clause 11.6, Ingress of liquids Clause 11.7, Biocompatibility (ISO ) Clause 14, Programmable electronic Systems Clause 17, EMC Assessment Manager: CG1 Page 2 of 5

3 SECTION 3: MEDICAL ELECTRICAL EQUIPMENT Medical electrical Electrical safety BS EN :1990, Amds 1 to 3 IEC :1988, Amds A1 and A2 Clause 29, Clause 36, EMC Clauses 37-41, Ignition of flammable anaesthetic mixtures Clause 44.6, Ingress of liquids Clause 44.7, Sterilization Clause 48, Biocompatibility (ISO ) Clause 52.1, Programmable electronic Systems Clause 59, Rubber ageing Safety requirements for medical electrical systems Electrical safety BS EN :1993, Amds 1 and 2 IEC :1992 Safety of high frequency surgical Electrical safety BS EN :1993, Amd 1 (withdrawn) IEC :1998 Electrocardiographs Electrical safety BS EN :1999 IEC :1993, Amd 1 Electrocardiograph monitoring Electrical safety BS EN :2005 IEC :2005 Non-invasive blood pressure monitoring Electrical safety BS EN :2000 IEC :1999 Clause 22.4, Cuff pressure Electricaly operated Hospital Beds Electrical safety BS EN : A1 IEC : A1 Testing can also be carried out at the customers premises Assessment Manager: CG1 Page 3 of 5

4 SECTION 4: INFORMATION TECHNOLOGY EQUIPMENT Information technology Electrical safety BS EN :2006 IEC :2005 Clause 7.3.2, Surge BS EN :2002 IEC :2001 Clause 7.3.2, Surge BS EN 60950:1992, Amds 1 to 5 (withdrawn) IEC 60950:1991, Amds 1 to 4 Where BS or IEC standards have exact equivalents in EN Standards, these EN standards are also included in the accreditation. END Assessment Manager: CG1 Page 4 of 5

5 Accreditation for the purpose of Notified Body Activity taking into account EA2/17 Directive / Regulation Conformity Assessment procedure/ Module/article Category of products or individual products Essential requirements: Product specification / Properties/Standards The Low Voltage Directive 2006/95/EC as implemented in the UK by The Electrical Equipment (Safety) Regulations 1994, No 3260 Reports to Article 8 and Opinions to Article 9 Audio, Video and Similar Electronic Apparatus IT and Telecommunications Equipment Measurement, Control and Laboratory Equipment Principal elements of the Safety Objectives requirements Annex I of the Directive and Schedule 3 of the Regulations. AUS-NZ MRA END Assessment Manager: CG1 Page 5 of 5