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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS 18784 : 2024

IS Title/आईएस शीर्षक : Medical Devices ï¿½ Sleep Apnoea Breathing Therapy ï¿½ Masks and Application Accessories

Superseding IS/सुपरसीडिंग आईएस : None

Degree of Equivalence/समतुल्यता स्तर : Modified/Technically Equivalent

Number of Revisions/पुनरीक्षणों की संख्या : New Standard

Number of Amendments/संशोधनों की संख्या : No amendment issued

Aspect/पक्ष : Product Specification

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 11 (Anesthetic, Resuscitation and Allied Equipment Sectional Committee)

Member Secretary/सदस्य सचिव : Mr. Satyam Rathore (SCIENTIST-B)

Other Details

Indian Standard

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Amendment : 0

Gazette Document : 1

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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 18784 : 2024
:

1	IS 13200 : 2023	Anaesthetic and Respiratory Equipment Vocabulary Second Revision	MHD 11
2	IS/ISO 4871 : 1996 ISO 4871 : 1996 Reviewed In : 2022	Acoustics - Declaration and Verification of Noise Emission Values of Machinery and Equipment	MED 7
3	IS/ISO 5356-1 : 2015 ISO 5356-1 : 2015 Reviewed In : 2022	Anaesthetic and respiratory equipment - Conical connectors: Part 1 cones and sockets (First Revision)	MHD 11
4	IS/ISO 5356-2 : 2012 Reviewed In : 2020	Anaesthetic and respiratory equipment - Conical connectors: Part 2 screw - Threaded weight - Bearing connectors	MHD 11
5	IS 17932 : Part 1 : 2023	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD)	MHD 19
6	IS/ISO 14937 : 2009	Sterilization of health care products General requirements for characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices	MHD 12
7	IS/ISO 15223-1 : 2016 ISO 15223-1 : 2016	Medical Devices — Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part 1 General Requirements ( Second Revision )	MHD 14
8	IS/ISO/IEC 23736-3 : 2020 ISO/IEC 23736-3: 2020	Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices	MHD 12
9	IS/ISO 8000-62 : 2018 ISO 8000-62 : 2022	Medical electrical equipment Part 2 - Particular requirements for basic safety and essential performance Section 70 : Sleep apnoea breathing therapy equipment	MHD 11
10	IS 13450 (Part 1) : 2024	Medical electrical equipment: Part 1 general requirements for basic safety and essential performance (Second Revision)	MHD 15
11	IS 18003 (Part 2) : 2021 Reviewed In : 2024
12	IS 18006 (Part 3/Sec 1) : 2021 Reviewed In : 2024

International Standards Referred In IS 18784 : 2024

Standard contains no Cross Referenced International Standard.

IS 18784 : 2024
is Referred in following Indian Standards :

1	IS 17928 : Part 2 : 2022	Plastics - Poly (methyl methacrylate) (pmma) moulding and extrusion materials : Part 2 preparation of test specimens and determination of properties	PCD 12
2	IS 4079 : 2023	PACKED RASOGOLLA ï¿½ SPECIFICATION (First Revision of IS 4079)	FAD 19
3	IS 4079 : 2023	PACKED RASOGOLLA ï¿½ SPECIFICATION (First Revision of IS 4079)	FAD 19

Classification Details

Group	:	Medical and Hospital Equipments
Sub Group	:	Clinical, pathological, anaesthetic and respiratory equipments and systems
Sub Sub Group	:	Diagnostic , anaesthetic and respiratory equipment
Aspect	:	Product Specification
Certification	:	Voluntary Certification
Relevant Ministries	:	Ministry of Health and Family Welfare
Sustainable development Goals :
Short Commom Man's Title	:
ITC-HS Code	:	N/A
Degree of Equivalence	:	Modified/Technically Equivalent
Identical/Equivalent International Standard(s)	:	ISO 17510: 2015
Harmonized with	:	ISO

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

List of Licenses under IS : IS 18784 : 2024

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

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Basic Details/ मूल ब्यौरा

Other Details

Indian Standard

Amendment : 0

Gazette Document : 1

License : 0

Product Manual & SIT : 0

Laboratory : 0

Classification Details

Cross Reference Details

Composition

Corrigendum : 0

Cross Reference Details

Classification Details

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List of Licenses under IS : IS 18784 : 2024

List of Expired or Cancelled Licenses under IS : IS 18784 : 2024

List of laboratories for : IS 18784 : 2024

List of Amendement(s) for : IS 18784 : 2024

List of Gazette Document(s) for : IS 18784 : 2024

List of Corigenda Document(s) for : IS 18784 : 2024

List of Product Manuals & SIT