Biological evaluation of medical devices — Part 1: Requirements and general principles for the evalu...
This document specifies:
— the general principles governing the biological evaluation of medical devices within a risk management process;
— the general categorization of medical devices based on the nature and duration of their contact with the body;
— the evaluation of existing relevant data from all sources;
— the identification of gaps in the available data…
Cybersecurity — Artificial Intelligence — Guidance for addressing security threats to artificial int...
This document provides guidance for organizations to address security threats and failures in artificial intelligence (AI) systems. The guidance in this document aims to provide information to organizations to help them better understand the consequences of security threats to AI systems, throughout their lifecycle, and descriptions of how to detect and mitigate such threats.
This document is…
Information technology — Metamodel framework for interoperability (MFI) — Part 13: Metamodel for for...
The primary purpose of the ISO/IEC 19763 series is to specify a metamodel framework for interoperability. ISO/IEC TS 19763-13(E) specifies a metamodel for registering form designs.
ISO/IEC TS 19763-13(E) provides a metamodel to describe the structure and semantics of an implemented form devoid of any specific, domain semantics, e.g. in healthcare, social science, e-government and e-business, or…
Road vehicles — On-board diagnostic communication — Part 3: Zero emissions vehicle propulsion system...
ISO/SAE 1979-3 is intended to satisfy the data reporting requirements of regulations in the United States and Europe, and any other market that may adopt similar requirements in the future.
This document specifies diagnostic services required to be supported by motor vehicles and external test equipment for diagnostic purposes which pertain to Zero Emission Vehicle (ZEV) propulsion related data…
Information security, cybersecurity and privacy protection — Privacy information management systems ...
This document specifies requirements for establishing, implementing, maintaining and continually improving a privacy information management system (PIMS).
Guidance is provided to assist in the implementation of the controls in this document.
This document is intended for PII controllers and PII processors holding responsibility and accountability for PII processing.
This document is applicable to…
Security and resilience — Community resilience — Guidelines to develop a local resilience capability...
This document provides guidelines for local government on establishing and managing cross-sector partnerships for societal resilience to disruptions arising from major emergencies, disasters, or crises. It covers how local government should lead the design and implementation of a strategy to build societal resilience to disruption, including:
- agreeing local government’s own ambition;
-…
Security controls and implementation for third party payment service providers - Guidance and requir...
This document provides security controls and implementation guides for the third party payment service providers (TPPSPs). These security controls consist of
- Security governance control group
- Cross-sectional control group
- Section-specific control group
- Audit and assurance control group
In ISO/AWI TS 9546, the guidelines for security framework of information…
Conformity assessment — Guidance for drafting normative documents suitable for use for conformity as...
This document provides principles and guidance for developing normative documents that contain:
specified requirements for objects of conformity assessment to fulfil;
specified requirements for conformity assessment systems that can be employed when demonstrating whether an object of conformity assessment fulfils specified requirements.
This document is intended for use by standards developers…
Exchange formats for audit data collection — Government regulated financial reports and payroll exte...
The Government Regulated Financial Reports and Payroll Extension (DIS 5405) defines the functional requirements for exchanging reports and payroll audit data in flat file tables. This proposal concerns the specification of technical exchange formats in Extensible Markup Language (XML), JavaScript Object Notation (JSON) and flat file (CSV) as output file formats for the functional content defined…
Financial services — Natural person identifier (NPI) — Natural person identifier lifecycle operation...
This document provides an overview of regulatory, business and best practice risk mitigation requirements that would apply to the implementation, operation and governance of NPI policies, procedures and mechanisms necessary to support the lifecycle of all NPIs. It also lists the issues and challenges the working group has come across since working on AWI 24366-2, which have to be addressed…
