Indian_standards - BIS Connect

Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS/ISO 11607 : 2019
ISO 11607-2:2019

IS Title/आईएस शीर्षक : Packing for Terminally Sterilized Medical Devices Part 2 Validation Requirements for Forming Sealing and Assembly Processes (First Revision)

Superseding IS/सुपरसीडिंग आईएस : None

Degree of Equivalence/समतुल्यता स्तर : Identical under single numbering

Number of Revisions/पुनरीक्षणों की संख्या : 1

Number of Amendments/संशोधनों की संख्या : No amendment issued

Aspect/पक्ष : Code of Practice

Language/भाषा : English

Reaffirmation Year/पुनर्पुष्टि वर्ष : No reaffirmation

Technical Department/तकनीकी विभाग : MHD (Medical Equipment and Hospital Planning Department)

Technical Committee/तकनीकी समिति : MHD 12 (Hospital Equipment and Surgical Disposable Products Sectional Committee)

Member Secretary/सदस्य सचिव : Ms. UROOSA WARSI (SCIENTIST-C)

Other Details

Indian Standard

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Amendment : 0

Gazette Document : 4

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License : 0

Product Manual & SIT : 0

Laboratory : 0

Classification Details

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Cross Reference Details

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Composition

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Corrigendum : 0

Cross Reference Details

Indian Standards Referred In IS IS/ISO 11607 : 2019
ISO 11607-2:2019
:

1	IS 7155 (Part 7) : 2023	Code of recommended practice for conveyor safety: Part 7 inspection and maintenance (First Revision)	MED 6

International Standards Referred In IS/ISO 11607 : 2019
ISO 11607-2:2019

Standard contains no Cross Referenced International Standard.

IS/ISO 11607 : 2019
ISO 11607-2:2019
is Referred in following Indian Standards :

1	IS/ISO 15223 : Part 2 : 2010	Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied: Part 2 symbol development, selection and validation	MHD 14
2	IS/ISO 15674 : 2016	Cardiovascular implants and artificial organs - Hard - Shell cardiotomy/venous reservoir systems (With/without Filter) and soft venous reservoir bags (Second Revision)	MHD 6
3	IS 17334 : 2019	Medical textiles – Surgical gowns and surgical drapes – Specification	TXD 36
4	IS 17348 : 2020	Medical textiles – Adhesive incise drape – Specification	TXD 36
5	IS 17350 : 2020	Medical textiles – Abdominal binder – Specification	TXD 36
6	IS 17351 : 2020	Medical textiles – Dressing, shell compressed – Specification	TXD 36
7	IS/ISO 5840 : Part 3 : 2013	Cardiovascular Implants Cardiac Valve Prostheses Part 3 Heart Valve Substitutes Implanted by Trans-Catheter Techniques	MHD 6
8	IS 17410 : 2020	Medical Textiles â€” Bio-Protective Coverall â€” Specification	TXD 36
9	IS 17506 : 2020	Medical Textiles - Hydrocolloid Dressing - Specification	TXD 36
10	IS/ISO 11607 : Part 2 : 2006	Packaging for terminally sterilized medical devices: Part 2 validation requirements for forming, sealing and assembly processes	MHD 12
11	IS/ISO 11607 : Part 1 : 2019	Packaging for terminally sterilized medical devices â€” Part 1: Requirements for materials sterile barrier systems and packaging systems First Revision	MHD 12
12	IS/IEC 60479 : Part 1 : 2018	Effects of current on human beings and livestock - Part 1: General Aspects	ETD 20
13	IS 17423 : 2020	Medical textiles – Coveralls for COVID 19 – Specification	TXD 36
14	IS 17545 : 2021	White cement based polymeric putty	CHD 20

Classification Details

Group	:	Medical and Hospital Equipments
Sub Group	:	Medical and Hospital Equipments
Sub Sub Group	:	Allied hospital equipment
Aspect	:	Code of Practice
Certification	:	Voluntary Certification
Relevant Ministries	:	Ministry of New and Renewable Energy
Sustainable development Goals :
Short Commom Man's Title	:
ITC-HS Code	:
Degree of Equivalence	:	Identical under single numbering
Identical/Equivalent International Standard(s)	:	ISO 11607-2:2019
Harmonized with	:	ISO

ID	Mailing list	Download
1	Committee members email list	Download
3	Additional mailing list	Download

List of Licenses under IS : IS/ISO 11607 : Part 2 : 2019

ID	Licence No.	Firm Name & Address	District	State	Validity Date	Status	Variety	Brand Name	Scale

ID	Licence No.	Firm Name & Address	District	State	Validity Date	Status	Variety	Brand Name	Scale

Know your standards

Basic Details/ मूल ब्यौरा

Other Details

Indian Standard

Amendment : 0

Gazette Document : 4

License : 0

Product Manual & SIT : 0

Laboratory : 0

Classification Details

Cross Reference Details

Composition

Corrigendum : 0

Cross Reference Details

Classification Details

Email Ids

List of Licenses under IS : IS/ISO 11607 : Part 2 : 2019

List of Expired or Cancelled Licenses under IS : IS/ISO 11607 : Part 2 : 2019

List of laboratories for : IS/ISO 11607 : Part 2 : 2019

List of Amendement(s) for : IS/ISO 11607 : Part 2 : 2019

List of Gazette Document(s) for : IS/ISO 11607 : Part 2 : 2019

List of Corigenda Document(s) for : IS/ISO 11607 : Part 2 : 2019

List of Product Manuals & SIT