
Loading...
Law Update
Quick note
Below is the official summary and the reference document preview. Use “Open PDF” for full screen view.
The Bureau of Indian Standards (BIS) has notified the establishment of five Indian Standards covering three very different areas: ENT medical equipment, Internet of Things (IoT) data-exchange platforms and toner cartridge yield testing for colour printers and multi-function devices. All five standards listed in the notification were established on 28 August 2026.
Two of the entries involve a transition from an older edition. IS 11319:1985 and IS/ISO/IEC 19798:2017, are scheduled to be withdrawn on 28 February 2027. Until that date the earlier editions listed in the Gazette continue concurrently with the newly established versions.
For businesses, the practical question is not simply whether a new standard exists. The more important questions are whether the standard is already being used in product specifications, testing, contracts or procurement documents, whether an older edition is still being referenced, and whether any separate regulatory instrument makes compliance with the standard compulsory.
| Particular | Verified Details |
| Issuing Authority | Bureau of Indian Standards (BIS) |
| Department | Department of Consumer Affairs |
| Document Type | Notification |
| Reference Number | HQ-PUB013/1/2020-PUB-BIS (1597) |
| Notification Date | 1 September 2026 |
| Gazette | Gazette of India, Extraordinary, Part III Section 4 |
| Gazette Issue Date | 8 September 2026 |
| Governing Provision | Rule 15(1), Bureau of Indian Standards Rules, 2018 |
| Standards Covered | 5 Indian Standards |
| Establishment Date | 28 August 2026 |
| Older Editions Scheduled for Withdrawal | IS 11319:1985 and IS/ISO/IEC 19798:2017 |
| Withdrawal Date | 28 February 2027 |
| Main Areas | ENT equipment, IoT, office printing equipment |
| Nature of Development | Establishment/revision of Indian Standards |
The notification was issued by BIS on 1 September 2026 under Rule 15(1) of the Bureau of Indian Standards Rules, 2018. It states that the Indian Standards listed in the schedule have been established on the dates shown and that any earlier standard identified for withdrawal will remain in force concurrently until the stated withdrawal date.
BIS has formally placed five Indian Standards on record through the Gazette notification. The schedule identifies the standard number, title, date of establishment and, where relevant, the earlier edition that is scheduled to be withdrawn.
The distinction between establishment and withdrawal matters.
The five standards were established on 28 August 2026, but this does not mean that the two previous editions listed in the notification stopped existing on that date. BIS has expressly allowed those earlier editions to continue concurrently until 28 February 2027.
This gives businesses using the older editions a clear date to review where those editions appear in their technical and commercial documentation.
The notification has been issued under Sub-rule (1) of Rule 15 of the Bureau of Indian Standards Rules, 2018. BIS uses this mechanism to notify the establishment of Indian Standards and, where relevant, identify standards that are to be withdrawn.
For businesses, however, the existence of an Indian Standard and the legal requirement to obtain BIS certification are not always the same thing.
An Indian Standard may be used as:
Whether certification, licensing, marking or compulsory compliance applies to a particular product has to be assessed separately under the relevant law, Quality Control Order (QCO), conformity-assessment scheme or other applicable regulatory instrument.
The notification covers the following five standards:
| Standard | Subject | Status | Establishment Date | Earlier Standard | Withdrawal Date |
| IS 11319:2026 | ENT Surgery Instruments — Oesophagoscope Negus Type Pattern — Specification | First Revision | 28 August 2026 | IS 11319:1985 | 28 February 2027 |
| IS/ISO/IEC 30161-1:2020 | IoT Data Exchange Platform for IoT Services — Part 1 | Established | 28 August 2026 | NA | NA |
| IS/ISO/IEC 30161-2:2023 | IoT Data Exchange Platform for IoT Services — Part 2 | Established | 28 August 2026 | NA | NA |
| IS/ISO/IEC 19798:2025 | Toner Cartridge Yield for Colour Printers and Multi-Function Devices | First Revision | 28 August 2026 | IS/ISO/IEC 19798:2017 | 28 February 2027 |
| IS 19810:2026 | ENT Workstation — Specification | Established | 28 August 2026 | NA | NA |
These entries are taken directly from the schedule to the BIS notification.
The five standards broadly fall into three areas: ENT and medical equipment, IoT and data-exchange technology, and office printing equipment.
IS 11319:2026 is titled “ENT Surgery Instruments- Oesophagoscope Negus Type Pattern- Specification” and is identified as the first revision.
It was established on 28 August 2026. The earlier standard, IS 11319:1985 - Specification for Oesophagoscope, Negus Type Pattern, is listed for withdrawal on 28 February 2027.
Businesses that currently refer to the 1985 edition in product specifications, technical documentation, purchasing requirements or testing arrangements should therefore identify where that reference is being used and assess whether changes are needed before the withdrawal date.
The Gazette itself does not reproduce the technical differences between the 1985 and 2026 editions. Those differences can only be assessed by reviewing the respective standards.
IS/ISO/IEC 30161-1:2020 - IoT Data Exchange Platform
IS/ISO/IEC 30161-1:2020 deals with an Internet of Things data exchange platform for IoT services, specifically Part 1 - General Requirements and Architecture.
The standard was established on 28 August 2026. The Gazette shows NA against both the earlier standard and withdrawal-date columns.
This means the notification does not identify an earlier edition that is being withdrawn as part of this entry.
The notification does not provide detailed architecture, cybersecurity, privacy or data-governance requirements. Those technical details would need to be read from the standard itself.
IS/ISO/IEC 30161-2:2023 - IoT Transport Interoperability
IS/ISO/IEC 30161-2:2023 covers Part 2 - Transport Interoperability Between Nodal Points for data exchange platforms used in IoT services.
It was also established on 28 August 2026. As with Part 1, the notification lists no earlier standard for withdrawal.
This standard may be relevant to technology businesses, system integrators or organisations that work with IoT platforms where the standard is used as a technical requirement.
The Gazette does not set out specific interoperability parameters or test methods, so those details should not be assumed from the notification alone.
IS/ISO/IEC 19798:2025 - Toner Cartridge Yield
IS/ISO/IEC 19798:2025 relates to the method for determining toner cartridge yield for colour printers and multi-function devices containing printer components.
The standard is identified as the first revision, and was established on 28 August 2026. It replaces, subject to the transition period IS/ISO/IEC 19798:2017, which is scheduled for withdrawal on 28 February 2027.
This is likely to be particularly relevant where manufacturers, testing teams, suppliers or buyers already use the 2017 edition as a technical or contractual reference.
The notification does not state specific yield values, testing cycles or measurement conditions. Those remain matters for the full standard.
IS 19810:2026 - ENT Workstation Specification
IS 19810:2026 is titled “ENT Workstation-Specification.”
It was established on 28, August 2026 and the notification lists no previous standard for withdrawal.
Manufacturers, suppliers or procurement teams dealing with ENT workstations may therefore wish to understand whether the standard is relevant to their product specifications or procurement requirements.
However, establishment of this standard should not by itself be read as proof that every ENT workstation requires a new BIS licence.
The five entries do not belong to one single industry. This makes sector-wise reading useful.
ENT and Medical Equipment
Two standards relate to ENT equipment:
Businesses working with such equipment may need to check whether these standards appear in existing product documents, customer specifications, tenders, internal quality systems or testing arrangements.
Relevant teams may include:
The notification itself does not state that every manufacturer or supplier in the wider medical-device sector is automatically covered.
Internet of Things and Digital Infrastructure
Two standards relate to IoT data-exchange platforms:
These may be relevant to businesses that design, integrate or specify IoT systems where these standards are used as technical references.
This can include:
The notification does not itself impose a separate registration or licence requirement on these businesses.
Printers, Multi-Function Devices and Toner Cartridge Yield
IS/ISO/IEC 19798:2025 relates to measuring toner cartridge yield for colour printers and multi-function devices.
The stakeholders most likely to review this transition are those who currently reference the 2017 edition in:
This does not mean every printer, or cartridge business automatically faces a new statutory duty. The exact effect depends on how the standard is being used and whether any separate mandatory framework applies.
The notification makes a useful distinction.
| Category | Standards |
| Revised standards with earlier editions scheduled for withdrawal | IS 11319:2026: IS/ISO/IEC 19798:2025 |
| Revised standards with earlier editions scheduled for withdrawal | IS 11319:2026: IS/ISO/IEC 19798:2025 |
For the first category, businesses have a clear transition issue to manage because an older edition remains in force for a limited period.
For the second category, the Gazette simply records NA against the earlier-standard and withdrawal fields. It is safer to say that no earlier edition is listed for withdrawal in this notification, rather than assuming that the standards have no regulatory or technical history at all.
Only two previous editions are specifically identified for withdrawal.
| Existing Standard | Revised Standard | Concurrent Validity Until | Withdrawal Date |
| IS 11319:1985 | IS 11319:2026 | 28 February 2027 | 28 February 2027 |
| IS/ISO/IEC 19798:2017 | IS/ISO/IEC 19798:2025 | 28 February 2027 | 28 February 2027 |
Both earlier editions remain concurrently in force until the date specified by BIS.
Concurrent validity means that the older standard listed in the Gazette does not disappear immediately when the revised edition is established.
For the two revised standards, there is a period during which:
That period runs until 28 February 2027.
This is useful for businesses because technical transitions rarely happen by changing one line in one document. An older standard may appear across drawings, quality manuals, supplier specifications, contracts, purchase orders or test instructions.
At the same time, concurrent validity should not be overread. The notification does not explain how every existing BIS licence, customer contract, tender or test report must be handled during this period. Those questions may depend on the applicable certification scheme, contract terms or other regulatory requirements.
| Date | Development | Why It Matters |
| 28 August 2026 | Five standards established | This is the date recorded for establishment of all five standards |
| 1 September 2026 | BIS notification issued | Formal notification date |
| 1 September 2026 | Gazette issue date | Date shown on the Gazette publication |
| 28 February 2027 | Two earlier editions scheduled for withdrawal | Relevant to IS 11319:1985 and IS/ISO/IEC 19798:2017 |
The Gazette clearly separates these dates. The establishment date should therefore not be confused with either the notification date or the withdrawal date.
The notification states that IS 11319:1985 and IS/ISO/IEC 19798:2017 are to be withdrawn on 28 February 2027.
Businesses still referring to either edition should therefore review why the old version continues to appear in their documents and whether the reference needs to be updated.
This does not automatically mean that:
Those issues cannot be decided from this Gazette notification alone. They depend on the applicable regulatory, contractual, technical or certification framework.
No automatic conclusion of mandatory BIS certification should be drawn from this notification alone.
The document establishes Indian Standards and specifies withdrawal arrangements for two earlier editions. It does not itself state that all products connected with these standards must immediately obtain a BIS licence, ISI Mark or another form of certification.
There are three separate questions businesses should keep apart.
1. Establishment of an Indian Standard
An Indian Standard may exist as a recognised technical specification or benchmark.
2. Compulsory Application of a Standard
A standard may become legally compulsory where a separate applicable law, order or regulatory instrument requires compliance with it.
A Quality Control Order, for example, may make compliance with a particular Indian Standard compulsory for a specified product. The existence of such a requirement must be verified separately.
3. BIS Certification or Licensing
Certification, marking and licensing requirements depend on the applicable BIS conformity-assessment scheme and the product-specific legal framework.
The attached Gazette does not, by itself, set out a new certification procedure for the five standards.
That distinction is important because treating every standards notification as a compulsory-certification order can result in unnecessary filings or incorrect compliance decisions.
The notification is focused on establishment, and withdrawal of standards. It does not expressly introduce a new:
This does not mean that none of these requirements can apply to the products concerned.
They may exist under another law, QCO, BIS certification scheme or product-specific regulatory framework. That position should be checked separately before a business decides that certification is either mandatory or unnecessary.
A technical old-versus-new comparison cannot be prepared from this Gazette alone because the notification does not reproduce the clauses of the old and revised standards.
What can be confirmed is the transition itself:
| Area | Earlier Standard | Revised Standard | Older Edition Withdrawal | Main Review Point |
| ENT surgery instrument | IS 11319:1985 | IS 11319:2026 | 28 February 2027 | Check where the 1985 edition is currently referenced |
| Toner cartridge yield | IS/ISO/IEC 19798:2017 | IS/ISO/IEC 19798:2025 | 28 February 2027 | Review testing and technical references using the 2017 edition |
The detailed differences in dimensions, testing methods, construction, performance or other technical conditions can only be confirmed by reading the actual standards.
The practical impact will differ depending on how a business uses the affected standard.
| Stakeholder | Relevant Area | Possible Impact | What to Review |
| ENT equipment manufacturers | IS 11319:2026, IS 19810:2026 | Technical references may need review | Specifications, drawings, quality documents |
| IoT platform providers | IS/ISO/IEC 30161 Parts 1 and 2 | New Indian Standards may become relevant to technical specifications | Architecture and interoperability references |
| Printer/cartridge businesses | IS/ISO/IEC 19798:2025 | Older testing reference may need transition review | Test procedures, yield claims, customer specifications |
| Testing/quality teams | Revised standards | Internal procedures may cite old editions | SOPs, test reports, quality manuals |
| Procurement teams | All relevant standards | Purchase specifications may use outdated references | POs, tenders, supplier documents |
| Importers/distributors | Product-specific | Imported product documentation may refer to an affected standard | Technical declarations and customer requirements |
Manufacturers
For manufacturers, the immediate task is usually to identify whether one of the affected standards already appears in existing documentation.
That review may cover:
The Gazette does not say that every one of these documents must be changed. The need for an update depends on whether the older standard is actually being used and on the wider regulatory or contractual position.
Testing and Quality Teams
Testing teams may need to look closely at edition numbers.
For example, a procedure may simply state IS/ISO/IEC 19798 without making it immediately obvious which edition is being followed.
Useful review areas include:
Existing reports should not automatically be treated as invalid just because a revised standard has been established. Their continued acceptability will depend on the purpose for which they are being used.
Procurement and Supplier-Quality Teams
Old standard references can easily stay in procurement records even after a newer edition has been issued. Procurement and supplier-quality teams should check:
It is worth checking these documents together because the buyer may refer to one edition while the supplier is working to another. This can cause unnecessary questions or disputes over what was ordered, supplied, and tested, even when the change does not create a new BIS certification requirement.
Importers and Distributors
Importers and distributors should first check whether products sold or supplied in India are described against one of the affected standards.
Where an overseas manufacturer, customer or distributor uses an earlier edition in technical documents, those references may need review.
The notification itself does not introduce a separate import permission or import licence requirement.
For businesses using IS 11319:1985 or IS/ISO/IEC 19798:2017, the easiest place to begin is a document search.
Look for the old standard number in:
The purpose is not to change every document automatically. It is to identify where an edition-specific reference exists and decide whether it remains appropriate.
Manufacturers using an older standard should review the following areas to understand what needs to change before the withdrawal date and avoid gaps during the transition.
1. Find every reference to the old edition
Search controlled and working documents for IS 11319:1985 or IS/ISO/IEC 19798:2017, depending on the product. This helps establish the real scale of the transition.
2. Compare the previous and revised editions
The Gazette confirms that a revision has taken place but does not explain the technical changes.
A technical comparison should therefore be made using the actual standards.
3. Check whether product specifications are affected
If the revised edition changes a technical parameter used by the business, design or production documents may need attention.
This point must be based on the actual standard, not assumed from the Gazette.
4. Review certification or licence documents where relevant
If the product already has a BIS licence, or another related approval, check whether BIS has issued any specific instruction for shifting to the revised standard. The licence, or approval may have its own conditions for handling the change.
5. Check supplier and customer specifications
Suppliers and customers may still be working with different editions while the change is taking place. Check which edition they are referring to before finalising specifications or orders, so there is no confusion later.
6. Review testing arrangements
If product testing currently refers to an older edition, the business should identify when, and how the revised edition will be used, subject to the relevant testing and certification framework.
7. Update controlled documents where required
Any changes should be handled through the company's existing document-control process rather than making informal edits across multiple departments.
8. Track 28 February 2027
For the two earlier editions identified in the Gazette, this is the notified withdrawal date.
Technical-standard transitions are not only a compliance-team issue.
Procurement and supplier-quality teams should check whether an older edition appears in:
Where different documents refer to different editions, the business should determine which reference is contractually or technically applicable rather than assuming the newest edition automatically controls every existing agreement.
The withdrawal of an older standard can create practical issues if technical, supplier, testing and certification documents are not reviewed together.
That creates confusion during testing, audit, supply or customer review.
This can lead to questions about what was actually ordered and tested.
Standards transition should therefore be checked across both technical and quality systems.
A supplier should not assume that a revised BIS standard automatically changes the wording of an existing tender or contract.
That should be checked against the applicable certification framework instead of being assumed.
A standard being established does not automatically mean a new BIS certification application is required under this Gazette notification.
An early review gives businesses more time to understand where the older standard is actually being used.
It can help with:
The benefit is mainly better control of the transition rather than any guaranteed commercial saving.
The main challenge is often not understanding that a new edition exists. It is finding every place where the old one has become part of day-to-day operations.
Businesses may face issues such as:
The actual cost and effort will differ from one business to another and are not specified in the notification.
Standards transitions can also create demand for specialised technical and regulatory support.
Potential areas include:
These opportunities depend on how businesses adopt the standards and whether the standards interact with separate mandatory regulatory requirements.
| Priority | Action | Relevant Team | Timing/Trigger | Purpose |
| High | Search for IS 11319:1985 or IS/ISO/IEC 19798:2017 references | Quality/Technical | Now, if currently used | Identify transition exposure |
| High | Check contracts, certification documents and test procedures | Legal/Compliance/Quality | Where applicable | Understand how the old edition is being used |
| Medium | Compare old and revised standards | Technical/Product | Before transition decision | Identify technical differences |
| Medium | Speak with suppliers and testing partners | Procurement/Quality | Where relevant | Avoid edition mismatch |
| Before 28 Feb 2027 | Resolve old-standard references where necessary | Relevant departments | Before notified withdrawal | Prepare for withdrawal |
| Ongoing | Monitor official BIS and product-specific directions | Compliance | Ongoing | Prepare for withdrawal Track further regulatory developments |
These are practical review steps, not a separate statutory process created by this notification.
Businesses affected by the five standards may need to monitor official developments such as:
Future action should be based on confirmed official material rather than an assumption that every revised standard will automatically become mandatory.
A revised or newly established standard does not always mean that a business should immediately start a certification application.
The first step is usually to understand the product, the standard being used, the applicable regulatory framework and whether any older edition is still embedded in current documents.
Corpseed can support businesses through relevant BIS compliance services, product compliance reviews and technical regulatory assistance.
1. BIS Regulatory Applicability Assessment
Corpseed can help businesses review:
This helps separate a standards update from a genuine certification obligation.
2. Standard Transition Review
Businesses already using an older edition may require a focused transition review. Corpseed can assist in examining:
This can help businesses decide where technical or compliance attention is actually needed.
3. BIS Certification and Compliance Support
Where a separate applicable legal framework requires BIS certification, Corpseed can support businesses with the relevant certification process.
The scope would depend on the exact product and the applicable certification scheme rather than on this standards-establishment notification alone.
4. Product Compliance Services
Corpseed's product compliance services can support businesses in understanding:
This can be useful where more than one legal or technical framework applies to the same product.
5. Technical Compliance Consulting
For businesses managing a standards transition, technical records often need as much attention as regulatory documents.
Corpseed can support the review of:
6. Product Testing and Laboratory Coordination
Where testing is required under an applicable standard or certification framework, Corpseed can assist businesses in understanding the testing requirement and coordinating with relevant laboratories.
The exact testing scope should always be based on the applicable standard and regulatory framework.
7. Existing BIS Licence Review
Businesses already holding a relevant BIS licence may need to check whether a revised edition affects their existing position.
The review may cover:
A licence should not be assumed to require amendment merely because a new edition has been established.
8. Compliance Gap Assessment
A compliance gap assessment can help businesses compare their present technical and regulatory position with the requirements that actually apply.
The review may look at:
Businesses using IS 11319:1985, IS/ISO/IEC 19798:2017, or any of the other standards listed in this notification can review their position before making technical or certification changes. Corpseed's BIS compliance services can support applicability assessment, standards-transition review, technical documentation and certification assistance where the applicable framework requires it.
Document Preview
Embedded reference document