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Core Purpose

Order notifying the Medical Textiles (Quality Control) Order, 2024, mandating BIS Standard Mark certification for specified medical textile products.

Detailed Summary

By S.O. 4634(E) dated 23rd October 2024, the Ministry of Textiles, exercising powers under section 16 read with section 17 and sub-section (3) of section 25 of the Bureau of Indian Standards Act, 2016 (11 of 2016) and after consulting the Bureau of Indian Standards, notified the Medical Textiles (Quality Control) Order, 2024, superseding the Medical Textiles (Quality Control) Order, 2023, and effective from the date of publication; the Order mandates that goods listed in Schedule A (sanitary napkins under IS 5405:2019, effective 1st January 2025; baby diapers under IS 17509:2021; and reusable sanitary pads/period panties under IS 17514:2021) and Schedule B (shoe covers under IS 17349:2020, effective 1st April 2024; dental bibs/napkins under IS 17354:2020; and bedsheets and pillow covers under IS 17630:2021) conform to the corresponding Indian Standards and bear the BIS Standard Mark under Scheme-I of Schedule-II to the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018, with the Bureau of Indian Standards and the Textiles Committee, Ministry of Textiles designated as the certifying and enforcing authorities; export goods and Schedule A items made by self-help groups are exempted; the Order is issued under File No. 6/1/2021-R&D(Pt.4) and signed by Rajeev Saxena, Joint Secretary.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-23102024-258180 EXTRAORDINARY PART II—Section 3—Sub-section (ii) PUBLISHED BY AUTHORITY No. 4260] NEW DELHI, WEDNESDAY, OCTOBER 23, 2024/KARTIKA 1, 1946 MINISTRY OF TEXTILES ORDER New Delhi, the 23rd October, 2024 S.O. 4634(E). In exercise of the powers conferred by section 16 read with section 17 and sub-section (3) of section 25 of the Bureau of Indian Standards Act, 2016 (11 of 2016) and in supersession of the Medical Textiles (Quality Control) Order, 2023, the Central Government is of the opinion that it is necessary so to do in the public interest and after consulting the Bureau of Indian Standards, hereby makes the following Order, namely:— 1. Short title and commencement — (1) This Order may be called the Medical Textiles (Quality Control) Order, 2024. (2) It shall come into force on the date of its publication in the Official Gazette. 2. Application – This Order shall apply to the goods or articles specified in column (2) of the said Schedules, but shall not apply to such goods or article meant for export and items specified in Schedule-A to this order that are manufactured by self help groups. Explanation For the purpose of this para, self help groups means small informal group of 10 to 20 individuals, who are homogenous with respect to social and economic background and come together voluntarily for promoting savings habit among members and for a common cause to raise and manage resources for the benefit of group members and in hilly tracts or regions and predominantly tribal dominated areas where communities are dispersed, smaller groups of minimum five members are also formed into self help groups. 3. Compulsory use of Standard Mark – The goods or article specified in column (2) of the said Schedules shall conform to the corresponding Indian Standard specified in column (3) thereof and shall bear the Standard Mark under a licence from the Bureau in accordance with Scheme-I of Schedule-II to the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018. 4. Certification and enforcement authority – The Bureau of Indian Standards and the Textiles Committee, Ministry of Textiles shall be the certifying and enforcing authority in respect of the goods or article specified in column (2) of the said Schedules. SCHEDULE A +-------+-----------------------------+-----------------------+-------------------------------------------------------------+------------------------+ | Sl. No. | Goods or article | Indian Standard (IS) | Title of Indian Standard | Timeline for | | | | | | implementation | +=======+=============================+=======================+=============================================================+========================+ | (1) | (2) | (3) | (4) | (5) | +-------+-----------------------------+-----------------------+-------------------------------------------------------------+------------------------+ | 1 | Sanitary napkins | IS 5405:2019 | Sanitary napkins - | 1st January 2025. | | | | | Specification (second | | | | | | revision) | | +-------+-----------------------------+-----------------------+-------------------------------------------------------------+------------------------+ | 2 | Baby Diaper | IS 17509:2021 | Disposable baby diaper - | | | | | | Specification | | +-------+-----------------------------+-----------------------+-------------------------------------------------------------+------------------------+ | 3 | Reusable Sanitary | IS 17514:2021 | Reusable sanitary pad/ sanitary | | | | Pad Sanitary | | napkin/ period panties - | | | | Napkin Period | | Specification | | | | Panties | | | | +-------+-----------------------------+-----------------------+-------------------------------------------------------------+------------------------+ SCHEDULE B +-------+-----------------------------+-----------------------+-------------------------------------------------------------+------------------------+ | Sl. No. | Goods or article | Indian Standard (IS) | Title of Indian Standard | Timeline for | | | | | | implementation | +=======+=============================+=======================+=============================================================+========================+ | (1) | (2) | (3) | (4) | (5) | +-------+-----------------------------+-----------------------+-------------------------------------------------------------+------------------------+ | 1 | Shoe covers | IS 17349:2020 | Medical textiles - Shoe | 1st April, 2024. | | | | | covers - Specification | | +-------+-----------------------------+-----------------------+-------------------------------------------------------------+------------------------+ | 2 | Dental bib/Napkins | IS 17354:2020 | Medical textiles - Dental Bib | | | | | | or Napkins - Specification | | +-------+-----------------------------+-----------------------+-------------------------------------------------------------+------------------------+ | 3 | Bedsheet and Pillow | IS 17630:2021 | Medical Textiles - Bed | | | | Cover | | sheet and pillow cover - | | | | | | Specification | | +-------+-----------------------------+-----------------------+-------------------------------------------------------------+------------------------+ Note: For the purposes of the Schedule A and Schedule B, it is clarified that the latest version of Indian Standards established and published by the Bureau of Indian Standards from time to time in accordance with the provisions of clause (17) of section 2 of the Bureau of Indian Standards Act, 2016 (11 of 2016), shall apply from the date of such publication. [F. No. 6/1/2021-R&D(Pt.4)] RAJEEV SAXENA, Jt. Secy. Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.

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