IS O/ TC 122 and ANS I/ MH 10 Committee S tructure S lides 1 - - PowerPoint PPT Presentation

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IS O/ TC 122 and ANS I/ MH 10 Committee S tructure S lides 1 to 4 from Patrick Davison Remaining slides by Jan Gates 9 April 2016 ISO/TC 122 Committees ISO/TC 122 Packaging US TAG Chair: Dan Kimball S C 3 S C 4 Performance

SLIDE 1

IS O/ TC 122 and ANS I/ MH 10

Committee S tructure

S lides 1 to 4 from Patrick Davison Remaining slides by Jan Gates 9 April 2016

SLIDE 2

ISO/TC 122 Committees

ISO/TC 122 – Packaging

US TAG Chair: Dan Kimball

S C 3

Performance requirement s and t est s for means of packaging, packages and unit loads

S C 4

Packaging and the environment

WG 3

Child resist ant cont ainers

WG 7

Random vibrat ion t est

WG 8

Transport packages for dangerous goods

WG 1

Terminology

WG 2

Opt imizat ion

WG 3

Reuse

WG 4

Recycling

WG 5

Energy recovery

WG 6

Chemical recovery

WG 7

Organic recovery

WG 8

Marking for Mat erial ID

WG 5

Terminology & Vocabulary

WG 9

Accessible design for packaging

WG 12

S .C. applicat ions of logist ics t echnology

WG 14

Label mat erial

WG 8

Plastic drums

WG 13

Ret urnable Transport S yst em

WG 11

Household goods & shipment s

Child Committees

TAG Administrator: ASTM Contact: Pat Nolan TAG Administrator: MHI Contact: Pat Davison

SLIDE 3

ANSI/MH 10 Committees

ANSI/MH10

Chair: Dan Kimball

S C 1

S izes and Dimensions Chair: Unfilled

S C 4

Packaging & Environment Chair: Fred Hayes

S C 3

Package Testing Standards Chair: Pat Nolan

S C 5

Definitions & Terminology Chair: Jan Gates

S C 8

Coding & Labeling of Unit-Loads Chair: Bob Fox

S C 9

Household Goods Shipments Chair: Brian Limperopulos

ANS I Committees IS O TAG Committee IS O TC 122 TAG

Chair: Dan Kimball

SLIDE 4

IS O/ TC122 Packaging

Total number of published ISO standards related to the TC and its SCs (number includes updates): 76 Number of published ISO standards under the direct responsibility of ISO/TC 122 (number includes updates): 41 Participating countries: 34 Observing countries: 44 Secretariat: JISC Twinned secretariat: ISIRI Secreary: Mr. Akira Shirakura Twinned secretary: Ms. Manijeh Abdi Chairperson: Dr Takeo Shiina until end 2020 ISO Technical Programme Manager: Mme Maho Takahashi ISO Editorial Programme Manager: Mr Francesco Dadaglio Creation date: 1966 Scope: Standardization in the field of packaging with regard to terminology and definitions, packaging dimensions, performance requirements and tests. Excluded : matters falling within the scopes of particular committees (e.g. TC 6, 52 and 104).

SLIDE 5

IS O/ TC 122

 Standards and projects under the direct responsibility of

ISO/TC 122 Secretariat = 54

 Standards and projects under the direct responsibility of

ISO/TC 122/SC 3 Secretariat = 27

 Standards and projects under the direct responsibility of

ISO/TC 122/SC 4 Secretariat = 10

SLIDE 6

IS O/ TC 198 S terilization of Health Care Products

Total number of published ISO standards related to the TC and its SCs (number includes updates): 54 Number of published ISO standards under the direct responsibility of ISO/TC 198 (number includes updates): 54 Participating countries: 27 Observing countries: 24

Secretariat: ANSI

Secretary: Ms Amanda Benedict Chairperson: Dr. Eamonn V. Hoxey until end 2016 ISO Technical Programme Manager: Dr Mary Lou Pelaprat ISO Editorial Programme Manager: Mrs. Laura Mathew Creation date: 1990 Scope: Standardization of processes and equipment for sterilization of health care products.

SLIDE 7

TC 198 S tandards

IS O 11135:2014 S t erilizat ion of healt h-care product s -- Et hylene oxide -- Requirement s for t he development , validat ion and rout ine cont rol of a st erilizat ion process for medical devices IS O 11137-1:2006 & Amd 1:2013S t erilizat ion of healt h care product s -- Radiat ion -- Part 1: Requirement s for development , validat ion and rout ine cont rol of a st erilizat ion process for medical devices IS O 11137-2:2013 S t erilizat ion of healt h care product s -- Radiat ion -- Part 2: Est ablishing t he st erilizat ion dose IS O 11137-3:2006 S t erilizat ion of healt h care product s -- Radiat ion -- Part 3: Guidance on dosimet ric aspect s IS O 11138-1:2006 S t erilizat ion of healt h care product s -- Biological indicat ors -- Part 1: General requirement s IS O 11138-2:2006 S t erilizat ion of healt h care product s -- Biological indicat ors -- Part 2: Biological indicat ors for et hylene oxide st erilizat ion processes IS O 11138-3:2006 S t erilizat ion of healt h care product s -- Biological indicat ors -- Part 3: Biological indicat ors for moist heat st erilizat ion processes IS O 11138-4:2006 S t erilizat ion of healt h care product s -- Biological indicat ors -- Part 4: Biological indicat ors for dry heat st erilizat ion processes IS O 11138-5:2006 S t erilizat ion of healt h care product s -- Biological indicat ors -- Part 5: Biological indicat ors for low-t emperat ure st eam and formaldehyde st erilizat ion processes IS O/ TS 11139:2006 S t erilizat ion of healt h care product s -- Vocabulary IS O 11140-1:2014 S t erilizat ion of healt h care product s -- Chemical indicat ors -- Part 1: General requirement s IS O 11140-3:2007 & / Cor 1:2007 S t erilizat ion of healt h care product s -- Chemical indicat ors -- Part 3: Class 2 indicat or syst ems for use in t he Bowie and Dick-t ype st eam penet rat ion t est IS O 11140-4:2007 S t erilizat ion of healt h care product s -- Chemical indicat ors -- Part 4: Class 2 indicat ors as an alt ernat ive t o t he Bowie and Dick-t ype t est for det ect ion of st eam penet rat ion IS O 11140-5:2007 S t erilizat ion of healt h care product s -- Chemical indicat ors -- Part 5: Class 2 indicat ors for Bowie and Dick-t ype air removal t est s

IS O 11607-1:2006 & Amd 1:2014 Packaging for t erminally st erilized medical devices -- Part 1: Requirements for mat erials, st erile barrier syst ems and packaging syst ems IS O 11607-2:2006& Amd 1:2014 Packaging for t erminally st erilized medical devices -- Part 2: Validat ion requirement s for forming, sealing and assembly processes

IS O 11737-1:2006 & Cor 1:2007 S t erilizat ion of medical devices -- Microbiological met hods -- Part 1: Det erminat ion of a populat ion of microorganisms on product s IS O 11737-2:2009 S t erilizat ion of medical devices -- Microbiological met hods -- Part 2: Test s of st erilit y performed in t he definit ion, validat ion and maint enance of a st erilizat ion process IS O/ TS 13004:2013 & Amd 1:2013 S t erilizat ion of healt h care product s -- Radiat ion -- S ubst ant iat ion of select ed st erilizat ion dose: Met hod VDmaxS D IS O 13408-1:2008 & Amd 1:2013 Asept ic processing of healt h care product s -- Part 1: General requirement s IS O 13408-2:2003 Asept ic processing of healt h care product s -- Part 2: Filt rat ion IS O 13408-3:2006 Asept ic processing of healt h care product s -- Part 3: Lyophilizat ion IS O 13408-4:2005 Asept ic processing of healt h care product s -- Part 4: Clean-in-place t echnologies IS O 13408-5:2006 Asept ic processing of healt h care product s -- Part 5: S t erilizat ion in place IS O 13408-6:2005 & Amd 1:2013 Asept ic processing of healt h care product s -- Part 6: Isolat or syst ems IS O 13408-7:2012 Asept ic processing of healt h care product s -- Part 7: Alt ernat ive processes for medical devices and combinat ion product s IS O 14160:2011 S t erilizat ion of healt h care product s -- Liquid chemical st erilizing agent s for single-use medical devices ut ilizing animal t issues and t heir derivat ives -- Requirement s for charact erizat ion, development , validat ion and rout ine cont rol of a st erilizat ion process for medical devices IS O 14161:2009 S t erilizat ion of healt h care product s -- Biological indicat ors -- Guidance for t he select ion, use and int erpret at ion of result s IS O 14937:2009 S t erilizat ion of healt h care product s -- General requirement s for charact erizat ion of a st erilizing agent and t he development , validat ion and rout ine cont rol of a st erilizat ion process for medical devices IS O 15882:2008 S t erilizat ion of healt h care product s -- Chemical indicat ors -- Guidance for select ion, use and int erpret at ion of result s IS O 15883-1:2006 & Amd 1:2014 Washer-disinfect ors -- Part 1: General requirement s, t erms and definit ions and t est s IS O 15883-2:2006 Washer-disinfect ors -- Part 2: Requirement s and t est s for washer-disinfect ors employing t hermal disinfect ion for surgical inst rument s, anaest het ic equipment , bowls, dishes, receivers, ut ensils, glassware, et c. IS O 15883-3:2006 Washer-disinfect ors -- Part 3: Requirement s and t est s for washer-disinfect ors employing t hermal disinfect ion for human wast e cont ainers IS O 15883-4:2008 Washer-disinfect ors -- Part 4: Requirement s and t est s for washer-disinfect ors employing chemical disinfect ion for t hermolabile endoscopes IS O/ TS 15883-5:2005 Washer-disinfect ors -- Part 5: Test soils and met hods for demonst rat ing cleaning efficacy IS O 15883-6:2011 Washer-disinfect ors -- Part 6: Requirement s and t est s for washer-disinfect ors employing t hermal disinfect ion for non-invasive, non-crit ical medical devices and healt hcare equipment IS O 15883-7:2016 Washer-disinfect ors -- Part 7: Requirement s and t est s for washer-disinfect ors employing chemical disinfect ion for non-invasive, non-crit ical t hermolabile medical devices and healt hcare equipment

IS O/ TS 16775:2014 Packaging for t erminally st erilized medical devices -- Guidance on t he application of IS O 11607-1 and IS O 11607-2

IS O 17664:2004 S t erilizat ion of medical devices -- Informat ion t o be provided by t he manufact urer for t he processing of rest erilizable medical devices IS O 17665-1:2006 S t erilizat ion of healt h care product s -- Moist heat -- Part 1: Requirement s for t he development , validat ion and rout ine cont rol of a st erilizat ion process for medical devices IS O/ TS 17665-2:2009 S t erilizat ion of healt h care product s -- Moist heat -- Part 2: Guidance on t he applicat ion of IS O 17665-1 IS O/ TS 17665-3:2013 S t erilizat ion of healt h care product s -- Moist heat -- Part 3: Guidance on t he designat ion of a medical device t o a product family and processing cat egory for st eam st erilizat ion IS O 18362:2016 Manufact ure of cell-based healt h care product s -- Cont rol of microbial risks during processing IS O 18472:2006 S t erilizat ion of healt h care product s -- Biological and chemical indicat ors -- Test equipment IS O 20857:2010 S t erilizat ion of healt h care product s -- Dry heat -- Requirement s for t he development , validat ion and rout ine cont rol of a st erilizat ion process for medical devices IS O 25424:2009 S t erilizat ion of medical devices -- Low t emperat ure st eam and formaldehyde -- Requirement s for development , validat ion and rout ine cont rol of a st erilizat ion process for medical devices

SLIDE 8

MHI General Meeting – 1 April 2016

 Reorganizing structure to match ISO committees  Pat Davison is working to reorganize the

MHI/MH10 structure and communications

 Dan Kimball is the ANSI/MHI0 – US Tag for TC122

 Current ly t raveling unt il June

 Two WG need leaders:  WG 13 Returnable Transport S

ystems

 WG 8 Plastic Drums

SLIDE 9

MHI/ MH10 Openings - Contacts

 Patrick Davison – Standards Director

Email: PDavison@

mhi.org

Telephone: 704.714.8755

 Dan Kimball - ANSI/MHI0, US Tag for TC122

Email: Danzz@

q.com

Telephone: 360.379.1994