SlideShare a Scribd company logo
Basic Safety, Essential Performance, and EMC  Frank O’Brien www.obcompman.com
Topics ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Topics ,[object Object],[object Object],[object Object]
Jurisdictional Authority ,[object Object],[object Object],[object Object],[object Object]
SC62A Working Groups ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Release Schedule 3 rd  Edition circulated.  Jurisdictions with Authority work to adopt with 3 to 5 year(?) transition Dec(?) 2005 FDIS circulated for final vote and typographical comments. Sep(?) 2005 Comments resolved, FDIS text submitted for editing check and French translation. Work begins on aligning Particulars and Collaterals Apr 2005 National Committees voted to circulate 2CDV as FDIS, (with 1400 comments)  Aug 2004
IEC 60601-1, Collaterals, Particulars Collateral Standards Particular Standards ,[object Object],[object Object],60601-2-2 High Frequency Surgical Equipment 60601-2-1 Medical Electron Accelerators 60601-2-38 Electrically Operated Hospital Beds 60601-2-50 Infant Phototherapy Equipment General Standard 60601-1 60601-1-2 EMC 60601-1-3 Radiation Protection 60601-1-6 Usability 60601-1-8 Alarms
Collaterals Inserted into General Standard IEC 60601-1, 3 rd  Edition IEC 60601-1-4, PEMS (software) Clause 14 IEC 60601-1-1, Systems Clause 16
Scope, Clause 1.1 ,[object Object]
Terminology, Clauses 3.63, 3.64 ,[object Object],[object Object],[object Object],[object Object],[object Object]
Terminology, Clauses 3.10, 3.27 ,[object Object],[object Object],[object Object],[object Object],[object Object]
Terminology, Clauses 3.39, 3.102,  3.38 ,[object Object],[object Object],[object Object],ISO 14971 Hazard Harm Risk
Risk Management Process, Clause 4.1, 4.2, 4.7 ,[object Object],[object Object],[object Object],[object Object]
Risk Management Process, 4.3 ,[object Object],[object Object],[object Object]
Risk Management Process ,[object Object],[object Object],[object Object],[object Object],[object Object]
Risk Management Process ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Risk Management Process ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Risk assessment Risk management ISO 14971 Figure 1
Risk Regions Negligible Marginal Critical Catastrophic Incredible Improbable Remote Occasional Probable Frequent Intolerable ALARP As Low As Reasonably Practicable Broadly Acceptable Probability Severity Example based on ISO 14971, Fig E.1
Development Life Cycle Process (facilitates risk mgt, not required) 1.Requirements, Analysis, Specifications 7. Systems Test 6. Integration Test 5. Module Test 4. Implementation 3. Detailed Design, Specification 2. Top-Level Design, Specification Verification Verification Validation Ongoing Risk Analysis Verification of Risk Controls Example based on Fig H.2 (PEMS)
New Requirements of Interest ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
New Requirements of Interest ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
New Requirements of Interest ,[object Object],[object Object],[object Object]
New Requirements of Interest ,[object Object],[object Object],[object Object],43 10 min < t 48 1 min  <  t < 10 min 60 t < 1 min Plastic Contact for time t Maximum Temperature, C APPLIED PART
EMC, IEC 60601-1-2:2001 ,[object Object],[object Object]
Major Changes to IEC 60601­1­2:2001 ,[object Object],[object Object],[object Object],[object Object],[object Object]
Major Changes to IEC 60601­1­2:2001 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Major Changes to IEC 60601­1­2:2001 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IEC 60601-1-2, Amendment1:2004-09 ,[object Object],[object Object],[object Object],[object Object]
EMC Essential Performance ,[object Object],[object Object],[object Object],[object Object]
Summary ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

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Massmedic mar2004g

  • 1. Basic Safety, Essential Performance, and EMC Frank O’Brien www.obcompman.com
  • 2.
  • 3.
  • 4.
  • 5.
  • 6. Release Schedule 3 rd Edition circulated. Jurisdictions with Authority work to adopt with 3 to 5 year(?) transition Dec(?) 2005 FDIS circulated for final vote and typographical comments. Sep(?) 2005 Comments resolved, FDIS text submitted for editing check and French translation. Work begins on aligning Particulars and Collaterals Apr 2005 National Committees voted to circulate 2CDV as FDIS, (with 1400 comments) Aug 2004
  • 7.
  • 8. Collaterals Inserted into General Standard IEC 60601-1, 3 rd Edition IEC 60601-1-4, PEMS (software) Clause 14 IEC 60601-1-1, Systems Clause 16
  • 9.
  • 10.
  • 11.
  • 12.
  • 13.
  • 14.
  • 15.
  • 16.
  • 17.
  • 18. Risk Regions Negligible Marginal Critical Catastrophic Incredible Improbable Remote Occasional Probable Frequent Intolerable ALARP As Low As Reasonably Practicable Broadly Acceptable Probability Severity Example based on ISO 14971, Fig E.1
  • 19. Development Life Cycle Process (facilitates risk mgt, not required) 1.Requirements, Analysis, Specifications 7. Systems Test 6. Integration Test 5. Module Test 4. Implementation 3. Detailed Design, Specification 2. Top-Level Design, Specification Verification Verification Validation Ongoing Risk Analysis Verification of Risk Controls Example based on Fig H.2 (PEMS)
  • 20.
  • 21.
  • 22.
  • 23.
  • 24.
  • 25.
  • 26.
  • 27.
  • 28.
  • 29.
  • 30.

Editor's Notes

  1. Explain – Series of Standards Graphic representation of collateral and particular standards Four collateral standards At least 50 particular standards Listed as –2-XX If a product does not fit into a particular standard, refer to one that is similar to use as a guide. For example, Midmark makes exam tables. No particular standard for exam tables, could look at operating tables, hospital beds standard for guidance.   Explain – When UL 60601-1 is used, I.e. to be able to use IEC 60950 equipment in the patient vicinity Discuss – EMC tests, 60601-1-2 Explain – 60601-1-3 x-ray Discuss – When to use 60601-1-4 software Explain – Additional collateral standards in development Discuss – Examples of particular standards and how they modify 60601-1 Explain – 60601-3-xx performance standard Explain 2 year effective date for US adoption of new IEC standards IEC standards writing process Instructor Note List of all published IEC standards for medical are available on the IEC website. http://www.iec.ch/searchpub/cur_fut.htm Conduct a search for IEC 60601 An option to search for works in progress is also available
  2. Explain – Risk Analysis Terms related to risk analysis State A hazard is a potential source of harm Explain Slide graphic When looking at risk, it is probability combined with severity of harm