Assess and designate Notified Bodies - TOPRA

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Vertical Harmonised Standards • Relate to specific types of device • All Harmonised Standards published on EU web site – Dates of publication in OJ – Dates of cessation of presumption of conformity – http://ec.europa.eu/enterprise/policies/europeanstandards/documents/harmonised-standardslegislation/list-references/medicaldevices/index_en.htm 28
Vertical Harmonised Standards Vertical Harmonised Standards (relate to specific device types) First publication OJ Reference of superseded standard Date of cessation of presumption of conformity of superseded standard EN ISO 15883-1:2009 Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006) 02/12/2009 EN ISO 15883- 1:2006 21/03/2010 EN ISO 15883-2:2009 02/12/2009 EN ISO 15883- 21/03/2010 Washer-disinfectors - Part 2: Requirements and tests for 2:2006 washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883- 2:2006) EN ISO 15883-3:2009 Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006) EN ISO 15883-4:2009 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008) 02/12/2009 EN ISO 15883- 3:2006 02/12/2009 EN ISO 15883- 4:2008 21/03/2010 21/03/2010 29
Page 2: Notified Bodies Neil Adams B.Sc. Ph
Page 5 and 6: In this presentation we will cover
Page 7 and 8: Conformity Assessment by Notified B
Page 9 and 10: 9 Role of the Member States • “
Page 11 and 12: Conformity Assessment Routes • If
Page 13 and 14: Conformity Assessment: Criteria for
Page 15 and 16: Conformity Assessment Procedures ma
Page 17 and 18: Conformity Assessment: Type Examina
Page 19 and 20: Conformity Assessment: Steps to CE-
Page 21 and 22: Manufacturer: Product to CE mark Co
Page 25 and 26: Use of Standards 2 5 • Manufactur
Page 27: Relationship between Standard and D
Page 31 and 32: Conformity assessment Notified Body
Page 33 and 34: Medical Devices Expert Group (MDEG)
Page 35 and 36: MEDDEVs 2.1 Scope, field of applica
Page 37 and 38: NB Recommendations • http://www.t
Page 39 and 40: NB-MED/2.5.1/Rec6 Renewal of EC Des
Page 41 and 42: NBOG Activities • Training for De
Page 45 and 46: We have covered • The roles and i
Page 47: QUESTIONS

Assess and designate Notified Bodies - TOPRA

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