IEC 60747-14-10:2019 PDF

Name: IEC 60747-14-10:2019 — Semiconductor devices - Part 14-10: Semiconductor sensors - Performance evaluation methods for wearable glucose sensors
SKU: IEC 60747-14-10:2019
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Semiconductor devices - Part 14-10: Semiconductor sensors - Performance evaluation methods for wearable glucose sensors

Название (английский):

IEC 60747-14-10:2019

Semiconductor devices - Part 14-10: Semiconductor sensors - Performance evaluation methods for wearable glucose sensors

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 64
Дата публикации:: 13 ноября 2019 г.
Издание:: IEC IS 60747 edition 1 version 1
ICS:: 31.080.01

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Описание (английский):

IEC 60747-14-10:2019 specifies the terms, definitions, symbols, tests, and performance evaluation methods used to determine the performance characteristics of wearable electrochemical-glucose sensors for practical use. This document is applicable to all wearable electrochemical-glucose sensors for consumers and manufacturers, without any limitations on device technology and size.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

IEC 60747-14-10:2019 establishes key performance evaluation methods for wearable glucose sensors based on semiconductor technology. Developed by the International Electrotechnical Commission (IEC), this standard is specifically applicable to wearable electrochemical-glucose sensors, without restrictions on device technology or size. The document defines essential terminology, symbols, characteristic parameters, and robust test procedures, ensuring consistent and reliable assessment of sensor function. Its scope addresses both consumer and manufacturer needs, helping to guide quality assurance, regulatory compliance, and product development in the rapidly expanding field of mobile health monitoring.

Key Topics

Comprehensive Definitions: The standard provides precise definitions for terms such as electrochemical-glucose sensor, electrode types (working, counter, reference), and sensor insertion types (implant, patch).

Characteristic Parameters: It details core parameters including:

Sensitivity – Relationship between current and glucose concentration
Selectivity – Ability to distinguish glucose from other substances
Response Time – Time for sensor output to stabilize after a change in glucose
Linearity – Proportionality between glucose concentration and sensor output
Repeatability & Reliability – Measurement precision under short and long-term conditions
Limit of Detection – Smallest reliably detectable glucose value
Accuracy & Reproducibility – Degree to which measurements match true glucose values across different conditions
Life-time – Duration of sensor effectiveness

Testing Protocols: The document specifies standardized test methods:

In Vitro Evaluation: Controlled laboratory testing for sensitivity, selectivity, and more
Preclinical Evaluation: Animal studies and robust testing prior to clinical use
Clinical Evaluation: Human trials to demonstrate safety and performance

Marking and Identification: Requirements for traceability, including manufacturer, serial number, and year/month of manufacture.

Applications

Adhering to IEC 60747-14-10:2019 is valuable for:

Medical Device Manufacturers: Enables standardized evaluation of wearable electrochemical-glucose sensors, supporting design validation, regulatory filings, and international market access.

Quality Assurance: Facilitates consistent testing across research, development, and production, enhancing product reliability and user safety.

Regulatory Compliance: Offers a clear framework for demonstrating conformity with international standards, aiding approval for medical devices.

Healthcare Providers & End-Users: Ensures that glucose monitoring sensors have been evaluated for critical parameters such as accuracy, response time, and selectivity, supporting better health outcomes for people with diabetes and related conditions.

Research & Development: Provides a basis for innovation and benchmarking of new sensor technologies in wearable health monitoring.

Related Standards

IEC 60747 Series: The comprehensive series on semiconductor devices offers further specifications applicable to related sensor and device types.

ISO 15197:2013: Specifies requirements for blood glucose monitoring systems used in self-testing for diabetes management. IEC 60747-14-10 provides complementary guidance for wearable devices and references the error grid analysis found in ISO 15197.

CLSI EP07-A2: Documented in the bibliography, this Clinical and Laboratory Standards Institute guideline focuses on interference testing in clinical chemistry and is referenced for selectivity testing methodologies.

By following the rigorous processes outlined in IEC 60747-14-10:2019, organizations can ensure their wearable glucose sensors are evaluated against internationally recognized benchmarks, leading to enhanced device performance, safety, and market acceptance in the field of semiconductor sensor technology for healthcare.

IEC 60747-14-10:2019 PDF

Abstract

Похожие стандарты

Overview

Key Topics

Applications

Related Standards

Технические детали

ISO 15197:2013

In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in mana…

BS IEC 60747-12-3:1998

Discrete semiconductor devices and integrated circuits - Optoelectronic devices. Blank detail specification f…

BS IEC 60747-14-10:2019

Semiconductor devices - Semiconductor sensors. Performance evaluation methods for wearable glucose sensors

SIST EN ISO 15197:2015

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in mana…