In pursuance of Subrule 1 of Rule 15 of the Bureau of Indian Standards Rules,

## Policy Analysis Report: Notification Regarding Indian Standards (September 17, 2021) **1. Executive Summary:** This report analyzes a notification issued by the Bureau of Indian Standards (BIS) on September 17, 2021. This notification, in pursuance of Subrule 1 of Rule 15 of the Bureau of Indian Standards Rules, 2018, establishes several new and revised Indian standards related to health care products, sugarcane harvesters, condoms, and spirometers. The core purpose is to notify stakeholders of these updated standards and their effective dates, along with any concurrent standards being withdrawn. The key finding is the update of standards for important product areas and their alignment with international standards in some cases. **2. Introduction:** This report provides an overview and analysis of a notification published by the Bureau of Indian Standards (BIS) on September 17, 2021, regarding the establishment and withdrawal of certain Indian Standards. The analysis is based solely on the information provided in the notification text. **3. Policy Overview:** This is a **New Policy** notification establishing and updating Indian Standards. * **Core Objective(s):** * To notify the establishment of new and revised Indian Standards. * To specify the effective dates of these standards. * To announce the withdrawal of concurrent standards, where applicable. * To ensure compliance with Subrule 1 of Rule 15 of the Bureau of Indian Standards Rules, 2018. **4. Background and Rationale:** As a **New Policy** notification, this likely addresses the ongoing need to maintain and update Indian Standards to reflect advancements in technology, industry best practices, and international standards. The specific areas covered (health care products, sugarcane harvesters, condoms, spirometers) suggest a focus on improving product quality, safety, and performance within these sectors. Furthermore, the reference to international standards (ISO) suggests an effort to align Indian standards with global benchmarks, likely facilitating trade and ensuring competitiveness. **5. Key Provisions / Changes:** As a **New Policy** notification, the main provisions are: * **Establishment of New Standards:** The notification establishes the following new Indian Standards with an effective date of September 17, 2021: * ISISO 134082:2018 - Aseptic Processing of Health Care Products Part 2 Sterilizing Filtration * IS 17626:2021 - Self-Propelled Sugarcane Harvester Test Methods * IS 17692:2021 - Male Condoms Guidance on the Use of Rubber Condoms ISISO 4074 and ISISO 23409 in the Guidance on the use of Quality Management of Condoms ISISO 4074 in the Quality First Revision Management of Natural Rubber Latex Condoms * ISISO 26782:2009 - Anaesthetic and Respiratory Equipment Spirometers Intended for the Measurement of Time Forced Expired Volumes in Humans * **Withdrawal of Concurrent Standards:** * ISISO 16038:2005 will be withdrawn on October 16, 2021 and the update for this standards is ISISO 16038:2017 * **Availability of Standards:** The notification indicates that copies of these standards are available for sale at BIS offices and can be purchased/downloaded online. **6. Target Audience and Stakeholders:** The target audience and stakeholders directly affected by this notification include: * Manufacturers of health care products, sugarcane harvesters, condoms, and spirometers. * Testing laboratories and certification bodies. * Procurement agencies (both public and private). * Consumers of the listed products. * Organizations involved in standardization and conformity assessment. **7. Implementation Aspects (Inferred):** * **Responsible Agency:** The Bureau of Indian Standards (BIS) is the responsible agency for implementing and enforcing these standards. * **Timelines:** The new standards are effective from September 17, 2021, with a withdrawal date of October 16, 2021 for ISISO 16038:2005 * **Conformity Assessment:** Manufacturers will likely need to update their production processes and quality control systems to comply with the new standards. They may also need to undergo testing and certification to demonstrate compliance. **8. Expected Outcomes / Impact of Changes:** The likely intended outcomes and impact of these changes are: * Improved quality and safety of health care products, sugarcane harvesters, condoms, and spirometers in the Indian market. * Enhanced competitiveness of Indian manufacturers through alignment with international standards. * Greater consumer confidence in the quality and reliability of products. * Harmonization of testing and certification procedures. **9. Conclusion:** The BIS notification of September 17, 2021, is a significant update to Indian Standards for various product categories. The establishment of new standards and the withdrawal of outdated ones aim to improve product quality, align with international best practices, and promote consumer safety. Manufacturers and other stakeholders in the affected industries need to familiarize themselves with these changes and take appropriate measures to ensure compliance. This notification underscores the BIS's commitment to maintaining relevant and up-to-date standards for the benefit of industry and consumers.

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