ANSI AAMI ISO 14155-2020 PDF

Full title and description

ANSI/AAMI/ISO 14155:2020 — Clinical investigation of medical devices for human subjects — Good clinical practice. This standard specifies good clinical practice (GCP) principles and detailed requirements for the design, conduct, recording and reporting of clinical investigations of medical devices involving human subjects, and defines responsibilities for sponsors, principal investigators, ethics committees and other stakeholders to ensure subject protection and credible results.

Abstract

ISO 14155:2020 establishes GCP for medical device clinical investigations to protect the rights, safety and well‑being of subjects and to ensure scientific integrity of investigation results. It is applicable to pre‑market and, where relevant, post‑market clinical investigations (with specific annex guidance), and includes principles, planning and conduct of studies, risk management, monitoring, auditing and reporting expectations.

General information

• Status: Published.
• Publication date: July 2020 (third edition; ISO publication late July 2020).
• Publisher: International Organization for Standardization (ISO); U.S. adoption/publisher: Association for the Advancement of Medical Instrumentation (AAMI) as ANSI/AAMI/ISO 14155:2020.
• ICS / categories: 11.100.20 (Biological evaluation of medical devices / clinical investigations).
• Edition / version: 3rd edition — ISO 14155:2020.
• Number of pages: 83 pages (ISO published document length).

Scope

ISO 14155:2020 covers good clinical practice for planning, conduct, recording and reporting of clinical investigations carried out in human subjects to assess clinical performance, effectiveness and safety of medical devices. It aims to protect human subjects and to ensure credible, scientifically valid results. The standard does not apply to in vitro diagnostic devices as a general rule, and for post‑market investigations it applies as far as relevant given the investigation type; users should consider national/regional regulatory requirements alongside the standard.

Key topics and requirements

• Summary of GCP principles for device clinical investigations (explicit principles included in Clause 4).
• Ethical considerations, informed consent and protection of subject rights and welfare.
• Clinical investigation planning: protocol content, feasibility, investigational device information and justification.
• Risk management integrated across planning, conduct and reporting (reinforced throughout the standard and annexes).
• Monitoring approaches including risk‑based monitoring and clinical quality management.
• Statistical considerations and analysis guidance (Annex A and related guidance).
• Roles and responsibilities of sponsor, principal investigator, ethics committees, CROs and other parties.
• Safety reporting, handling of adverse events, suspension/termination and study close‑out.
• Audits, inspection readiness and documentation / data integrity requirements.
• Guidance on applicability to Software as a Medical Device (SaMD) where relevant and justification for any exemptions.

Typical use and users

Primary users are medical device manufacturers and sponsors, principal investigators and clinical research organizations (CROs). Other users include institutional review boards/ethics committees, notified bodies / conformity assessment bodies, and regulatory authorities reviewing clinical evidence for regulatory submissions and conformity assessments. The standard is used to design clinical investigation protocols, manage study conduct, prepare regulatory‑grade clinical reports and to guide inspections and audits.

Related standards

Commonly referenced and complementary documents include ICH E6 (GCP) for drug trials (where applicable for principles), ISO 14971 (risk management for medical devices), ISO 13485 (medical device quality management system), and applicable regional regulations such as the EU Medical Device Regulation (MDR) and national regulatory guidance (e.g., FDA IDE requirements). Users typically apply ISO 14155 together with device risk‑management and QMS standards to satisfy regulatory and quality expectations.

Keywords

clinical investigation, good clinical practice, medical devices, sponsor responsibilities, principal investigator, risk‑based monitoring, informed consent, clinical protocol, adverse event reporting, SaMD, ISO 14155, ANSI/AAMI.

FAQ

Q: What is this standard?

A: ISO 14155:2020 (adopted in the U.S. as ANSI/AAMI/ISO 14155:2020) is the international good clinical practice standard for clinical investigations of medical devices in human subjects, describing ethical and scientific requirements for planning, conducting, recording and reporting device clinical studies.

Q: What does it cover?

A: It covers GCP principles, ethics, protocol content and study planning, risk management, monitoring (including risk‑based monitoring), statistical considerations, safety reporting, study suspension/termination and close‑out, roles and responsibilities of sponsors and investigators, and expectations for documentation and audits.

Q: Who typically uses it?

A: Device manufacturers and sponsors, principal investigators, CROs, ethics committees/IRBs, notified bodies and regulatory authorities use the standard to design and assess clinical investigations and to prepare regulatory submissions and audit/inspection materials.

Q: Is it current or superseded?

A: The 2020 third edition (ISO 14155:2020) supersedes the 2011 edition. As of publication it is the current edition; users should verify national adoptions or any later amendments or corrigenda that may apply in their jurisdiction.

Q: Is it part of a series?

A: ISO 14155 is a standalone ISO standard focused on clinical investigations of medical devices; it is frequently used alongside other medical‑device standards and guidance documents (for example ISO 14971 on risk management and ISO 13485 on QMS) to create a complete compliance framework.

Q: What are the key keywords?

A: Key keywords include clinical investigation, good clinical practice (GCP), medical device clinical study, sponsor, principal investigator, risk management, monitoring, adverse event reporting, SaMD, ISO 14155 and ANSI/AAMI adoption.