October 2026: New Standards Advance Health Care Technology

The health care technology sector reached a significant milestone in October 2026 with the release of five cutting-edge international standards. Addressing patient safety, medical accessibility, biomedical products, and assistive device requirements, these new standards are set to shape compliance frameworks and drive technological advancement across the industry. Professionals in medical device manufacturing, clinical procurement, facility infrastructure, and traditional medicine will find critical new requirements and best practices outlined in this comprehensive overview.

Overview / Introduction

Modern health care technology operates within a landscape defined by stringent standards to ensure safety, performance, and inclusivity. International standards play a vital role in harmonizing expectations across jurisdictions, streamlining procurement, and safeguarding patient wellbeing. For professionals, staying abreast of the latest specifications is essential for regulatory compliance, product design, and maintaining public trust.

This article explores the five newly published standards from October 2026:

• Pressure regulators integrated with medical gas cylinders
• Assistive products for toileting, bathing, and showering
• Tactile lettering for Braille and raised characters
• Quality and safety of traditional Chinese medicinal plant materials
• Requirements for acrylic resin cements used in surgery

We detail each standard’s purpose, scope, requirements, and real-world impact, making this a must-read for medical device engineers, regulatory specialists, research managers, and procurement authorities.

Detailed Standards Coverage

prEN ISO 10524-3 – Pressure Regulators Integrated with Cylinder Valves

Pressure regulators for use with medical gases – Part 3: Pressure regulators integrated with cylinder valves (VIPRs) (ISO/DIS 10524‑3:2025)

This new standard is dedicated to pressure regulators that are incorporated directly into the valves of gas cylinders, known as valves with integrated pressure regulators (VIPRs). These are critical in the delivery of medical gases—such as oxygen and medical air—to patients in both clinical and homecare scenarios. Designed for refillable cylinders with a working pressure up to 30,000 kPa (300 bar), the standard ensures VIPRs provide both safety and consistent gas flow during therapeutic use and tool operation.

Key requirements include:

• Design and type testing for safety, usability, material compatibility, and environmental durability
• Contamination control measures within gas pathways, ensuring minimization of infection and impurity risks
• Rigorous cleaning, mechanical strength, leak testing, and resistance to ignition
• Explicit marking and packaging procedures for traceability and compliance
• User-focused instructions for use and technical maintenance guidance

Applicable across hospitals, ambulatory care, and home settings, compliance ensures uninterrupted patient therapy and robust risk management for gas suppliers and device manufacturers. Notable changes bring enhanced test methodologies and broadened usability requirements compared to prior editions.

Key highlights:

• Expanded design validation and leak resistance testing
• Detailed cleaning/disinfection standards for infection control
• Comprehensive marking and packaging instructions

Access the full standard:View prEN ISO 10524-3 on iTeh Standards

ISO 17966:2026 – Assistive Products for Toileting, Bathing, and Showering

Assistive products for toileting, bathing and showering — Requirements and test methods

ISO 17966:2026 offers comprehensive requirements and testing procedures for a broad category of assistive products—including commode chairs, adjustable toilets, toilet seats with built-in raising mechanisms, splash guards, bath/shower chairs and supports, bathing stretchers, and grab rails. With increasing emphasis on independent living and dignity for persons with disabilities, this standard addresses functional, safety, and ergonomic aspects for both users and caregivers.

The standard provides:

• General and risk management requirements for product safety
• Specifications for materials, biocompatibility, infection prevention, and resistance to corrosion
• Explicit criteria for static strength, impact, and durability
• Stringent test methods for mechanical wear, stability, fall prevention, and hygienic performance
• Ergonomic mandates to ensure comfort and accessibility during normal use and foreseeable misuse
• Electromagnetic and electrical safety guidelines, plus warning device requirements

Organizations involved in medical device manufacturing, health facility procurement, and disability support services must adhere to these thorough requirements, including test cycles, strength formulae, and evidence-based design evaluation. This revision notably expands the divisions from ISO 9999:2022, thoroughly updating coverage for modern assistive solutions.

Key highlights:

• Integrated failure and misuse analysis for added patient safety
• Joint requirements for user and caregiver ergonomics
• Cross-division test methods for hygiene and longevity

Access the full standard:View ISO 17966:2026 on iTeh Standards

EN 18156:2026 – Tactile Lettering for Accessibility in the Built Environment

Tactile lettering – Requirements on the presentation and application of Braille and raised characters

A landmark document for universal design and accessibility, EN 18156:2026 specifies technical and ergonomic requirements for tactile lettering—including both Braille and raised characters—in built environments. This impacts all settings where accessibility for the blind and partially sighted is essential: hospitals, clinics, care homes, public facilities, and transit points.

Key requirements of the standard:

• Content, design, layout, and application rules to maximize legibility and ease of use
• Specifications for dimension, material durability, finish, and luminance contrast
• Detailed criteria for spacing, placement, and mounting of Braille/raised text on signage, handrails, and operational elements
• Requirements for tactile symbols and QR codes as supplementary aids
• Definitions and best practices referencing ISO 21542 “Accessibility and usability of the built environment” and EN 17210

Adhering to EN 18156:2026 ensures facility managers, architects, sign manufacturers, and compliance officers deliver information that is reliably accessible. This standard profoundly supports inclusivity by formalizing tactile communication, going well beyond visual information delivery.

Key highlights:

• Unified design principles for tactile and visual legibility
• Updated guidance on durability, UV-resistance, and non-allergic materials
• Expanded application to permanent built environment installations

Access the full standard:View EN 18156:2026 on iTeh Standards

ISO 25657:2026 – Traditional Chinese Medicine: Curculigo Orchioides Rhizome

Traditional Chinese medicine — Curculigo orchioides rhizome

Addressing the growing international trade and use of traditional medicinals, ISO 25657:2026 sets out rigorous quality and safety requirements for the Curculigo orchioides rhizome—an herb extensively used in Chinese, Kampo, and Indian medicine. This applies to the whole root material and decoction pieces sold as Chinese materia medica.

The standard covers:

• Morphological, chemical, and microscopical characteristics for authentic identification
• Limits on moisture, total ash, heavy metals, and pesticide residues, referencing ISO 18664 and ISO 22258
• TLC and marker compound test protocols for standardization and purity
• Sampling, packaging, storage, and labelling requirements to maintain quality throughout the supply chain
• Recommendations for storage, transportation, and traceability compliance

Pharmaceutical suppliers, herbal medicine processors, import/export authorities, and regulatory agencies are the primary users. Adoption ensures product quality, reduces adulteration risk, and supports international market trust. Highlights include harmonization of quality standards and methodologies for marker compound quantification, responding to recent global health trade demands.

Key highlights:

• Unified approach for morphological and microscopical ID
• Strict thresholds for chemical and biological contaminants
• Internationally applicable recommendations for trade and distribution

Access the full standard:View ISO 25657:2026 on iTeh Standards

ISO 5833:2026 – Implants for Surgery: Acrylic Resin Cements

Implants for surgery — Acrylic resin cements

ISO 5833:2026 provides the definitive criteria for acrylic resin cements used in the fixation of internal orthopaedic prostheses. The standard specifies physical, mechanical, packaging, and labelling requirements for two main cement types: those used with syringes and those in a dough state. Emphasizing patient and surgical safety, the requirements ensure every batch of cement meets sterility and performance criteria before use in surgery.

Among the critical specifications:

• Setting times, doughing times, maximum exothermic temperatures to control handling and patient safety
• Compressive and bending strength thresholds (≥70 MPa, ≥50 MPa respectively)
• Criteria for component accuracy, appearance, biocompatibility, and leachable monomer monitoring
• Mandatory test methods for stability, viscosity (including extrusion and intrusion), compressive strength, and bending modulus
• Thorough labelling and packaging protocols for traceability and safe implementation

This updated third edition includes numerous key changes, including enhanced biocompatibility requirements and expanded test methodologies, aligning with advances in surgical techniques. Manufacturers, procurement professionals, and clinical quality managers will benefit from the clear technical test methods and robust documentation mandates.

Key highlights:

• Additional requirements for dual-usage (syringe and dough)
• Strengthened biocompatibility, stability, and labelling sections
• Detailed physical and mechanical test methods for compliance

Access the full standard:View ISO 5833:2026 on iTeh Standards

Industry Impact & Compliance

The release of these October 2026 standards marks a significant shift in health care technology operations. For manufacturers, these documents set clearer expectations for design, validation, and post-market surveillance. Clinical facilities and procurement officers now have up-to-date benchmarks for purchasing decisions and facility upgrades.

Compliance with these new requirements will:

• Reduce risk of product failure and adverse events
• Support regulatory approvals in international markets
• Strengthen patient and caregiver safety across a wide range of products
• Enhance facility accessibility and inclusivity

Companies are advised to review compliance timelines in their jurisdictions. Early adoption supports smoother audits, product certifications, and market competitiveness while minimizing the costs and delays associated with corrective actions or recalls.

Failure to comply could result in regulatory penalties, loss of market access, and increased legal liability. Engaging in targeted training, supply chain review, and technical gap analysis is highly recommended.

Technical Insights

Several technical themes are shared across these standards:

• Robust type testing and validation protocols: Covering mechanical, chemical, and biological properties
• Sterility and contamination prevention: Strict mandates for everything from orthopaedic cements to medical gas devices
• User-centered design and risk management: Enhanced requirements for usability, especially in accessibility and assistive devices
• Documentation and traceability: Comprehensive marking, labelling, and report documentation enable transparency and recall effectiveness
• Testing best practices: Quality managers should ensure labs follow referenced ISO/ASTM methodologies and maintain up-to-date calibration and validation processes
• Certification readiness: Preparing full technical files and supporting evidence, including performance data and biocompatibility reports

Organizations should foster internal cross-disciplinary teams to interpret and deploy these standards, engaging engineers, regulatory affairs, clinicians, and quality professionals throughout implementation.

Conclusion / Next Steps

The October 2026 release of these international standards ushers in a new era for health care technology, emphasizing safety, accessibility, and global harmonization. Key actions for organizations include:

• Reviewing detailed standard documents and updating internal procedures
• Initiating staff training and supplier engagement sessions
• Performing compliance gap analyses against new requirements
• Coordinating with notified bodies for certification timelines and documentation

Staying informed positions your business at the forefront of health care innovation and regulatory confidence. For full access to these critical standards and ongoing updates, visit iTeh Standards, your trusted platform for international compliance and quality excellence.