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Medical Textiles (Quality Control) Order, 2023

Medical Textiles (Quality Control) Order, 2023

Medical Textiles (Quality Control) Order, 2023

 

[27th September 2023]

In exercise of the powers conferred by sub-sections (1) and (2) of section 16 read with section 17 and sub-section (3) of section 25 of the Bureau of Indian Standards Act, 2016 (11 of 2016), 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:-

Order - 1. Short title and commencement

(1)     This Order may be called the Medical Textiles (Quality Control) Order, 2023.

(2)     It shall come into force immediately after such periods, as specified item-wise in column (5) of the Schedule - A and Schedule - B annexed to this Order, from the date of its publication in the Official Gazette.

Order - 2. Application

This Order shall apply to 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 (SHGs).

Explanation. - For The purpose of This para, -

Self Help Groups (SHGs) 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. However, in hilly tracts or regions and predominantly tribal dominated areas where communities are dispersed, smaller groups of minimum 5 members are also formed into Self Help Groups (SHGs).

Order - 3. Compulsory use of Standard Mark

The goods or article specified in column (2) of the said Schedule shall conform to the corresponding Indian Standard specified in column (3) thereof and shall bear the Standard Mark under a license from the Bureau of Indian Standards in accordance with Scheme - I of Schedule - II to the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018.

Order - 4. Certifying and enforcement authority

The Bureau of Indian Standards shall be the certifying and enforcing authority in respect of the goods or article specified in column (2) of the said Schedule - A and Schedule - B.

Order - 5. Penalty for contravention

Any person, who contravenes the provisions of this Order, shall be punishable in accordance with the provisions of the Bureau of Indian Standards Act, 2016 (11 of 2016).

 

SCHEDULE 1




3




 

 

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 - Specification (second revision)

 

For Small & Micro Enterprises (SME) 1 st October 2024

 

For Others 1 st April 2024




 

2

 

Baby Diaper

 

IS 17509:2021

 

Disposable baby diaper - Specification

 

 

Reusable Sanitary Pad Sanitary Napkin Period Panties

 

IS 17514:2021

 

Reusable sanitary pad/ sanitary napkin/ period panties -Specification

 

SCHEDULE 2




3




 

 

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 covers - Specification

 

1 st April 2024

 




 

2

 

Dental bib/Napkins

 

IS 17354:2020

 

Medical textiles - Dental Bib or Napkins - Specification

 

 

Bedsheet and Pillow Cover

 

IS 17630:2021

 

Medical Textiles - Bed 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.