Standard Guide for Ensuring the Safety of Connected Consumer Products

SIGNIFICANCE AND USE
4.1 This guide is intended to apply in conjunction with applicable end-product specific performance or design standard requirements to address the overall system safety of a connected consumer product. Designers and manufacturers of a connected consumer product, with assistance from conformity assessment bodies, or others, as deemed desirable, should identify applicable and relevant product standards. They should assess and document if or how connectivity potentially affects the ability of such products to meet overall product-safety requirements, as well as conflicts or requirements, if any, that may or should not be applicable to the connected consumer product. This guide recognizes that the overall system safety of the connected consumer product is the primary objective. Property damage, including non-functionality of the connected consumer product, is only included to the extent that such property damage poses a risk of personal injury. Data security beyond the extent necessary to ensure system safety, or privacy-related issues, are not addressed in this guide although measures to address the protection of personal information may help mitigate connected consumer product safety issues.  
4.2 This guide provides guidelines for:  
4.2.1 Remote updates;  
4.2.2 Software, firmware, and configuration risk management designed to ensure compliance with an end product safety standard and to prevent the creation of an unanticipated hazard from the connected consumer product; and  
4.2.3 Cybersecurity risk controls for the software, firmware, and configuration of architecture and design.
SCOPE
1.1 This guide provides guidance for connected consumer products, as defined in 1.1.1, as it relates to physical product safety hazards created by virtue of their connectivity. It applies to connected products that need testing and evaluation to prevent cybersecurity vulnerabilities and weaknesses that could compromise the safety-related performance of the product, create a physical safety hazard in the product or its operation, or result in a noncompliance to the underlying end product safety standard.  
1.1.1 Connected consumer product or Internet of Things (IoT) consumer device means any consumer device or physical object that is capable of connecting to the internet or other network, directly or indirectly, and is assigned an internet, Bluetooth, or other communication protocol address or identifier. A non-exhaustive list of examples includes:
1.1.1.1 Connected children’s products such as toys and juvenile products such as baby monitors;
1.1.1.2 Connected safety-related products such as smoke alarms and door locks;
1.1.1.3 Connected TVs and speakers;
1.1.1.4 Wearable connected health trackers and smart apparel;
1.1.1.5 Connected home automation, security or surveillance cameras, and alarm systems;
1.1.1.6 Connected appliances (for example, washing machines and refrigerators); and
1.1.1.7 Connected smart home assistants.  
1.2 Safety, for this guide, is defined as the freedom from an unreasonable risk of physical injury or illness resulting from mechanical contact, hazardous energy release, or exposure to hazardous chemicals from the connected product. Physical injury or illness may include burns, lacerations, strains, contusions, suffocation, strangulation, poisoning, disease, seizures, internal injuries, shock, or other injuries to the body. Property damage related to non-functionality of the connected device is only included to the extent that such property damage leads to a safety issue. Safety, for this standard, does not include privacy or personal data security, or physical harms potentially resulting from privacy or personal data breaches.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and deter...

General Information

Status
Published
Publication Date
31-Aug-2021
Technical Committee
F15 - Consumer Products
Drafting Committee
F15.75 - Connected Products

Overview

ASTM F3463-21: Standard Guide for Ensuring the Safety of Connected Consumer Products provides crucial guidance for manufacturers and designers aiming to ensure the safe operation of connected consumer products, including Internet of Things (IoT) devices. Issued by ASTM International, this standard offers a framework for addressing safety risks that arise from the connectivity features of consumer products, focusing specifically on avoiding unreasonable risk of physical injury or illness caused by mechanical contact, hazardous energy, or exposure to hazardous chemicals. While the standard does not directly address privacy or data security issues unless they are linked to physical safety, it aims to ensure that connectivity does not introduce product safety hazards or lead to noncompliance with applicable end-product safety standards.

Key Topics

  • Applicability: The guide applies to a wide range of network-connected consumer products, such as children's toys, baby monitors, smart home assistants, wearable health trackers, connected appliances, and home automation systems.
  • System Safety: Emphasizes the importance of system-wide safety for connected devices, acknowledging that connectivity should not compromise compliance with existing product safety standards.
  • Risk Assessments: Recommends conducting structured assessments like Failure Mode and Effects Analysis (FMEA) and fault tree analysis to identify potential hazards related to connectivity.
  • Software and Firmware Updates: Stipulates guidelines for managing risks related to remote software and firmware updates to avoid unanticipated safety hazards.
  • Cybersecurity Controls: Focuses on implementing cybersecurity measures for connected devices, but only to the extent needed to uphold system safety and compliance.
  • Design Considerations: Advises manufacturers to carefully consider the architectural impact of third-party controllers, interfaces, and the likelihood that connectivity could impair device safety, especially for vulnerable populations such as children and the elderly.
  • Conformity Assessment: Outlines principles for evaluating connected consumer products against relevant safety standards, proposing both self-declaration and third-party assessments.

Applications

The ASTM F3463-21 standard is designed for practical use across various stages of product development and deployment:

  • Product Design and Manufacture: Assists product designers in integrating safety-by-design principles for IoT devices and connected products, reducing the risk of physical hazards caused by connectivity features.
  • Lifecycle Management: Guides manufacturers in establishing configuration management, version control for software and firmware, and ongoing monitoring to ensure continued compliance and safety throughout the product's lifecycle.
  • Incident Response and Vulnerability Assessment: Helps organizations build effective systems for collecting and analyzing incident data related to connected features and perform regular vulnerability assessments to identify potential cybersecurity threats that may impact physical safety.
  • Product Testing and Evaluation: Supports laboratories, importers, and retailers in testing new releases or firmware updates for safety impacts, ensuring ongoing adherence to established safety norms.
  • Safety Warnings and Notifications: Encourages the implementation of user alerts or warnings if safety controls are compromised due to connectivity, enhancing user awareness and mitigation of hazards.

Related Standards

  • NISTIR 8259: IoT Device Security Baseline (NIST recommendations for device manufacturers)
  • ETSI TS 103 645: Cyber Security for Consumer Internet of Things
  • UK Code of Practice for Consumer IoT Security: Industry guidance on IoT product security best practices
  • UL 5500: Standard for Safety for Remote Software Updates
  • ANSI/CAN/UL 2900-1: Standard for Software Cybersecurity for Network-Connectable Products
  • ISO/IEC 27000 Series: Information Security Management Systems
  • ISO/IEC 15408: Evaluation Criteria for IT Security
  • California SB-327: Cybersecurity of Connected Devices legislation

Keywords: connected consumer products, IoT safety, product safety standards, remote updates, cybersecurity risk controls, safety-by-design, conformity assessment, ASTM F3463-21

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Frequently Asked Questions

ASTM F3463-21 is a guide published by ASTM International. Its full title is "Standard Guide for Ensuring the Safety of Connected Consumer Products". This standard covers: SIGNIFICANCE AND USE 4.1 This guide is intended to apply in conjunction with applicable end-product specific performance or design standard requirements to address the overall system safety of a connected consumer product. Designers and manufacturers of a connected consumer product, with assistance from conformity assessment bodies, or others, as deemed desirable, should identify applicable and relevant product standards. They should assess and document if or how connectivity potentially affects the ability of such products to meet overall product-safety requirements, as well as conflicts or requirements, if any, that may or should not be applicable to the connected consumer product. This guide recognizes that the overall system safety of the connected consumer product is the primary objective. Property damage, including non-functionality of the connected consumer product, is only included to the extent that such property damage poses a risk of personal injury. Data security beyond the extent necessary to ensure system safety, or privacy-related issues, are not addressed in this guide although measures to address the protection of personal information may help mitigate connected consumer product safety issues. 4.2 This guide provides guidelines for: 4.2.1 Remote updates; 4.2.2 Software, firmware, and configuration risk management designed to ensure compliance with an end product safety standard and to prevent the creation of an unanticipated hazard from the connected consumer product; and 4.2.3 Cybersecurity risk controls for the software, firmware, and configuration of architecture and design. SCOPE 1.1 This guide provides guidance for connected consumer products, as defined in 1.1.1, as it relates to physical product safety hazards created by virtue of their connectivity. It applies to connected products that need testing and evaluation to prevent cybersecurity vulnerabilities and weaknesses that could compromise the safety-related performance of the product, create a physical safety hazard in the product or its operation, or result in a noncompliance to the underlying end product safety standard. 1.1.1 Connected consumer product or Internet of Things (IoT) consumer device means any consumer device or physical object that is capable of connecting to the internet or other network, directly or indirectly, and is assigned an internet, Bluetooth, or other communication protocol address or identifier. A non-exhaustive list of examples includes: 1.1.1.1 Connected children’s products such as toys and juvenile products such as baby monitors; 1.1.1.2 Connected safety-related products such as smoke alarms and door locks; 1.1.1.3 Connected TVs and speakers; 1.1.1.4 Wearable connected health trackers and smart apparel; 1.1.1.5 Connected home automation, security or surveillance cameras, and alarm systems; 1.1.1.6 Connected appliances (for example, washing machines and refrigerators); and 1.1.1.7 Connected smart home assistants. 1.2 Safety, for this guide, is defined as the freedom from an unreasonable risk of physical injury or illness resulting from mechanical contact, hazardous energy release, or exposure to hazardous chemicals from the connected product. Physical injury or illness may include burns, lacerations, strains, contusions, suffocation, strangulation, poisoning, disease, seizures, internal injuries, shock, or other injuries to the body. Property damage related to non-functionality of the connected device is only included to the extent that such property damage leads to a safety issue. Safety, for this standard, does not include privacy or personal data security, or physical harms potentially resulting from privacy or personal data breaches. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and deter...

SIGNIFICANCE AND USE 4.1 This guide is intended to apply in conjunction with applicable end-product specific performance or design standard requirements to address the overall system safety of a connected consumer product. Designers and manufacturers of a connected consumer product, with assistance from conformity assessment bodies, or others, as deemed desirable, should identify applicable and relevant product standards. They should assess and document if or how connectivity potentially affects the ability of such products to meet overall product-safety requirements, as well as conflicts or requirements, if any, that may or should not be applicable to the connected consumer product. This guide recognizes that the overall system safety of the connected consumer product is the primary objective. Property damage, including non-functionality of the connected consumer product, is only included to the extent that such property damage poses a risk of personal injury. Data security beyond the extent necessary to ensure system safety, or privacy-related issues, are not addressed in this guide although measures to address the protection of personal information may help mitigate connected consumer product safety issues. 4.2 This guide provides guidelines for: 4.2.1 Remote updates; 4.2.2 Software, firmware, and configuration risk management designed to ensure compliance with an end product safety standard and to prevent the creation of an unanticipated hazard from the connected consumer product; and 4.2.3 Cybersecurity risk controls for the software, firmware, and configuration of architecture and design. SCOPE 1.1 This guide provides guidance for connected consumer products, as defined in 1.1.1, as it relates to physical product safety hazards created by virtue of their connectivity. It applies to connected products that need testing and evaluation to prevent cybersecurity vulnerabilities and weaknesses that could compromise the safety-related performance of the product, create a physical safety hazard in the product or its operation, or result in a noncompliance to the underlying end product safety standard. 1.1.1 Connected consumer product or Internet of Things (IoT) consumer device means any consumer device or physical object that is capable of connecting to the internet or other network, directly or indirectly, and is assigned an internet, Bluetooth, or other communication protocol address or identifier. A non-exhaustive list of examples includes: 1.1.1.1 Connected children’s products such as toys and juvenile products such as baby monitors; 1.1.1.2 Connected safety-related products such as smoke alarms and door locks; 1.1.1.3 Connected TVs and speakers; 1.1.1.4 Wearable connected health trackers and smart apparel; 1.1.1.5 Connected home automation, security or surveillance cameras, and alarm systems; 1.1.1.6 Connected appliances (for example, washing machines and refrigerators); and 1.1.1.7 Connected smart home assistants. 1.2 Safety, for this guide, is defined as the freedom from an unreasonable risk of physical injury or illness resulting from mechanical contact, hazardous energy release, or exposure to hazardous chemicals from the connected product. Physical injury or illness may include burns, lacerations, strains, contusions, suffocation, strangulation, poisoning, disease, seizures, internal injuries, shock, or other injuries to the body. Property damage related to non-functionality of the connected device is only included to the extent that such property damage leads to a safety issue. Safety, for this standard, does not include privacy or personal data security, or physical harms potentially resulting from privacy or personal data breaches. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and deter...

ASTM F3463-21 is classified under the following ICS (International Classification for Standards) categories: 35.110 - Networking; 35.240.95 - Internet applications. The ICS classification helps identify the subject area and facilitates finding related standards.

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Standards Content (Sample)


This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F3463 − 21
Standard Guide for
Ensuring the Safety of Connected Consumer Products
This standard is issued under the fixed designation F3463; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
This guide is intended to provide direction for the design and manufacture of connected consumer
products to help ensure that the connected functionality of such products does not pose physical
hazards to consumers. This guidance should provide considerations for designing connected
functionality that neither poses nor introduces product safety hazards.
The focus of this guide is limited to consumer products.While the Internet ofThings (IoT) presents
one system for connecting products, this proposed guidance also covers other types of network-
connected systems such as Bluetooth, WiFi, or other communication protocols used with consumer
products.
1. Scope 1.1.1.7 Connected smart home assistants.
1.1 This guide provides guidance for connected consumer 1.2 Safety, for this guide, is defined as the freedom from an
products, as defined in 1.1.1, as it relates to physical product unreasonable risk of physical injury or illness resulting from
safety hazards created by virtue of their connectivity. It applies mechanical contact, hazardous energy release, or exposure to
to connected products that need testing and evaluation to hazardous chemicals from the connected product. Physical
prevent cybersecurity vulnerabilities and weaknesses that injury or illness may include burns, lacerations, strains,
could compromise the safety-related performance of the contusions, suffocation, strangulation, poisoning, disease,
product, create a physical safety hazard in the product or its seizures, internal injuries, shock, or other injuries to the body.
operation, or result in a noncompliance to the underlying end Property damage related to non-functionality of the connected
product safety standard. device is only included to the extent that such property damage
1.1.1 Connected consumer product or Internet of Things leads to a safety issue. Safety, for this standard, does not
(IoT) consumer device means any consumer device or physical include privacy or personal data security, or physical harms
object that is capable of connecting to the internet or other potentially resulting from privacy or personal data breaches.
network, directly or indirectly, and is assigned an internet,
1.3 This standard does not purport to address all of the
Bluetooth, or other communication protocol address or identi-
safety concerns, if any, associated with its use. It is the
fier. A non-exhaustive list of examples includes:
responsibility of the user of this standard to establish appro-
1.1.1.1 Connected children’s products such as toys and
priate safety, health, and environmental practices and deter-
juvenile products such as baby monitors;
mine the applicability of regulatory limitations prior to use.
1.1.1.2 Connected safety-related products such as smoke
1.4 This international standard was developed in accor-
alarms and door locks;
dance with internationally recognized principles on standard-
1.1.1.3 Connected TVs and speakers;
ization established in the Decision on Principles for the
1.1.1.4 Wearable connected health trackers and smart ap-
Development of International Standards, Guides and Recom-
parel;
mendations issued by the World Trade Organization Technical
1.1.1.5 Connected home automation, security or surveil-
Barriers to Trade (TBT) Committee.
lance cameras, and alarm systems;
1.1.1.6 Connected appliances (for example, washing ma-
2. Referenced Documents
chines and refrigerators); and
2.1 Federal Standard:
15 USC 2025(a)(5) Consumer Product Safety Act
This guide is under the jurisdiction of ASTM Committee F15 on Consumer
Products and is the direct responsibility of Subcommittee F15.75 on Connected
Products.
Current edition approved Sept. 1, 2021. Published November 2021. Originally Available from U.S. Government Printing Office, Superintendent of
approved in 2020. Last previous edition approved in 2020 as F3463 – 20. DOI: Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, http://
10.1520/F3463-21. www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F3463 − 21
3. Terminology 3.1.9 safety controls, n—features (for example, systems,
devices, and processes) within a connected consumer product
3.1 Definitions:
or system designed to mitigate one or more specific safety
3.1.1 connected consumer product, n—anyconsumerdevice
risks.
or physical object that is capable of connecting to the internet
3.1.10 vulnerable sub-populations, n—groups identified as
or other network directly or indirectly and is assigned an
often less able to perceive or avoid certain hazards associated
internet, Bluetooth, or other communication protocol address
with a consumer product or in the home environment.
or identifier.
3.1.10.1 Discussion—U. S. Consumer Product Safety Com-
3.1.2 consumer product, n—as defined in 15 USC
mission (CPSC) regulations identify children, the elderly, and
2052(a)(5)oftheCPSA;anyarticle,orcomponentpartthereof,
the handicapped as vulnerable sub-populations.
produced or distributed (i) for sale to a consumer for use in or
3.2 Definitions of Terms Specific to This Standard:
around a permanent or temporary household or residence, a
3.2.1 authenticated user, n—user granted access to the
school, in recreation, or otherwise, or (ii) for the personal use,
product’s operating systems through a qualified logon process
consumption or enjoyment of a consumer in or around a
that verifies the user credentials and authentication factors,
permanent or temporary household or residence, a school, in
such as a password, personal identification number (PIN),
recreation, or otherwise; such term does not include:
keychain fobs, smartphone two-factor codes, biometrics, or
(A) any article which is not customarily produced or
other similar measures.
distributed for sale to, or use or consumption by, or enjoyment
3.2.2 authorized user, n—user-granted express or implied
of, a consumer;
legitimate access or permission to operate a connected con-
(B) tobacco and tobacco products subject to FTC and/or
sumer product.
FDA regulation;
3.2.3 failure mode and effects analysis (FMEA),
(C) motor vehicles or motor vehicle equipment subject to
n—structured approach to identifying potential failures that
NHTSA regulation;
may exist within the design of a product or process that result
(D) pesticides subject to EPA registration, except to the
in a physical safety hazard or non-compliance with an end
extent that the Poison Prevention Packaging Act may apply;
product safety standard.
(E) firearms, their accessories, and ammunition subject to
3.2.3.1 Discussion—Failure modes are the ways in which a
BATFE regulation;
process can fail. Effects are the ways that these failures can
(F) aircraft, aircraft engines, propellers, or appliances sub-
lead to defects, or harmful outcomes for the customer.
ject to FAA regulation;
3.2.4 fault tree analysis, n—deductive procedure used to
(G) boats, vessels, appurtenances to vessels, and accesso-
determine the various combinations of hardware and software
riesandotherequipmentsubjecttoUSCoastGuardregulation;
failures and human errors that could cause undesired events at
(H) drugs, medical devices, or cosmetics subject to FDA
the system level.
regulation, except to the extent that the Poison Prevention
Packaging Act may apply;
3.2.5 safety-by-design principle, n—concept intended for
(I) food subject to FDA and/or USDA regulation. product designers to apply in order to achieve a safe product
through implementing hazard identification, risk assessment,
3.1.3 cyber security, n—protection against network-based
and risk control processes at each stage of the design process
threats that could lead to criminal or unauthorized access to the
by considering and documenting reasonably foreseeable use of
connected consumer product or to data obtained from the
the product and taking measures to either eliminate hazards or
connected consumer product that could result in an introduced
minimize risks as early in the design life cycle as possible or
hazard to the product or noncompliance with an underlying
provide a default on-product fail-safe mode.
standard, including the measures taken to achieve this.
3.2.6 smart, adj—termindicatingthatanitemisaconnected
3.1.4 firmware, n—machine instructions (programs) in-
product.
stalled on the memory chip or other programmable component
3.2.7 software patch, n—publicly released software update
of a connected consumer product intended to provide instruc-
to repair one or more known bugs or issues.
tions for the execution of the product’s operating functions.
3.1.5 hazard, n—potential source of physical injury.
4. Significance and Use
3.1.6 Internet of Things, IoT, n—system of connected prod- 4.1 This guide is intended to apply in conjunction with
ucts (consumer and non-consumer) that transfer data at local, applicableend-productspecificperformanceordesignstandard
national, and global levels. requirements to address the overall system safety of a con-
nected consumer product. Designers and manufacturers of a
3.1.7 remote update, n—update of a consumer connected
connected consumer product, with assistance from conformity
product in which its embedded software, firmware, or configu-
assessment bodies, or others, as deemed desirable, should
ration data is changed through a connection to the Internet.
identify applicable and relevant product standards. They
3.1.8 reasonable and foreseeable future, n—use of a con- should assess and document if or how connectivity potentially
nected consumer product in a manner that may result from
affects the ability of such products to meet overall product-
reasonably predictable human behavior. safetyrequirements,aswellasconflictsorrequirements,ifany,
F3463 − 21
thatmayorshouldnotbeapplicabletotheconnectedconsumer 5.3 Connected consumer product manufacturers, importers,
product.Thisguiderecognizesthattheoverallsystemsafetyof and/or retailers should:
the connected consumer product is the primary objective.
5.3.1 Apply the safety-by-design principle, including a de-
Property damage, including non-functionality of the connected fault fail-safe mode or a failure mode that alerts the consumer
consumer product, is only included to the extent that such
to an impaired condition;
property damage poses a risk of personal injury. Data security
5.3.2 Conduct safety assessments of connected consumer
...


This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F3463 − 20 F3463 − 21
Standard Guide for
Ensuring the Safety of Connected Consumer Products
This standard is issued under the fixed designation F3463; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
This guide is intended to provide direction for the design and manufacture of connected consumer
products to help ensure that the connected functionality of such products does not pose physical
hazards to consumers. This guidance should provide considerations for designing connected
functionality that neither poses nor introduces product safety hazards.
The focus of this guide is limited to consumer products. While the Internet of Things (IoT) presents
one system for connecting products, this proposed guidance also covers other types of network-
connected systems such as Bluetooth, WiFi, or other communication protocols used with consumer
products.
1. Scope
1.1 This guide provides guidance for connected consumer products, as defined in 1.1.1, as it relates to physical product safety
hazards created by virtue of their connectivity. It applies to connected products that need testing and evaluation to prevent
cybersecurity vulnerabilities and weaknesses that could compromise the safety-related performance of the product, create a
physical safety hazard in the product or its operation, or result in a noncompliance to the underlying end product safety standard.
1.1.1 Connected consumer product or Internet of Things (IoT) consumer device means any consumer device or physical object
that is capable of connecting to the internet or other network, directly or indirectly, and is assigned an internet, Bluetooth, or other
communication protocol address or identifier. A non-exhaustive list of examples includes:
1.1.1.1 Connected children’s toys;products such as toys and juvenile products such as baby monitors;
1.1.1.2 Connected safety-related products such as smoke alarms and door locks;
1.1.1.3 Connected TVs and speakers;
1.1.1.4 Wearable connected health trackers and smart apparel;
1.1.1.5 Connected home automation, security or surveillance cameras, and alarm systems;
1.1.1.6 Connected appliances (for example, washing machines and refrigerators); and
1.1.1.7 Connected smart home assistants; andassistants.
This guide is under the jurisdiction of ASTM Committee F15 on Consumer Products and is the direct responsibility of Subcommittee F15.75 on Connected Products.
Current edition approved Sept. 15, 2020Sept. 1, 2021. Published October 2020November 2021. Originally approved in 2020. Last previous edition approved in 2020 as
F3463 – 20. DOI: 10.1520/F3463-20.10.1520/F3463-21.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F3463 − 21
1.1.1.8 Connected baby monitors.
1.2 Safety, for this guide, is defined as the freedom from an unreasonable risk of physical injury or illness resulting from
mechanical contact, hazardous energy release, or exposure to hazardous chemicals from the connected product. Physical injury or
illness may include burns, lacerations, strains, contusions, suffocation, strangulation, poisoning, disease, seizures, internal injuries,
shock, or other injuries to the body. Property damage related to non-functionality of the connected device is only included to the
extent that such property damage leads to a safety issue. Safety, for this standard, does not include privacy or personal data security,
or physical harms potentially resulting from privacy or personal data breaches.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of
regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2.1 Federal Standard:
15 USC 2025(a)(5) Consumer Product Safety Act
3. Terminology
3.1 Definitions:
3.1.1 connected consumer product, n—any consumer device or physical object that is capable of connecting to the internet or other
network directly or indirectly and is assigned an internet, Bluetooth, or other communication protocol address or identifier.
3.1.2 consumer product, n—as defined in 15 USC 2052(a)(5) of the CPSA; any article, or component part thereof, produced or
distributed (i) for sale to a consumer for use in or around a permanent or temporary household or residence, a school, in recreation,
or otherwise, or (ii) for the personal use, consumption or enjoyment of a consumer in or around a permanent or temporary
household or residence, a school, in recreation, or otherwise; such term does not include:
(A) any article which is not customarily produced or distributed for sale to, or use or consumption by, or enjoyment of, a
consumer;
(B) tobacco and tobacco products subject to FTC and/or FDA regulation;
(C) motor vehicles or motor vehicle equipment subject to NHTSA regulation;
(D) pesticides subject to EPA registration, except to the extent that the Poison Prevention Packaging Act may apply;
(E) firearms, their accessories, and ammunition subject to BATFE regulation;
(F) aircraft, aircraft engines, propellers, or appliances subject to FAA regulation;
(G) boats, vessels, appurtenances to vessels, and accessories and other equipment subject to US Coast Guard regulation;
(H) drugs, medical devices, or cosmetics subject to FDA regulation, except to the extent that the Poison Prevention Packaging
Act may apply;
(I) food subject to FDA and/or USDA regulation.
3.1.3 cyber security, n—protection against network-based threats that could lead to criminal or unauthorized access to the
connected consumer product or to data obtained from the connected consumer product that could result in an introduced hazard
to the product or noncompliance with an underlying standard, including the measures taken to achieve this.
3.1.4 firmware, n—machine instructions (programs) installed on the memory chip or other programmable component of a
connected consumer product intended to provide instructions for the execution of the product’s operating functions.
3.1.5 hazard, n—potential source of physical injury.
Available from U.S. Government Printing Office, Superintendent of Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, http://www.access.gpo.gov.
F3463 − 21
3.1.6 Internet of Things, IoT, n—system of connected products (consumer and non-consumer) that transfer data at local, national,
and global levels.
3.1.7 remote update, n—update of a consumer connected product in which its embedded software, firmware, or configuration data
is changed through a connection to the Internet.
3.1.8 reasonable and foreseeable future, n—use of a connected consumer product in a manner that may result from reasonably
predictable human behavior.
3.1.9 safety controls, n—features (for example, systems, devices, and processes) within a connected consumer product or system
designed to mitigate one or more specific safety risks.
3.1.10 vulnerable sub-populations, n—groups identified as often less able to judgeperceive or escapeavoid certain hazards
associated with a consumer product or in the home environment.
3.1.10.1 Discussion—
U. S. Consumer Product Safety Commission (CPSC) regulations identify children, the elderly, and the handicapped as vulnerable
sub-populations.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 authenticated user, n—user granted access to the product’s operating systems through a qualified logon process that verifies
the user credentials and authentication factors, such as a password, personal identification number (PIN), keychain fobs,
smartphone two-factor codes, biometrics, or other similar measures.
3.2.2 authorized user, n—user-granted express or implied legitimate access or permission to operate a connected consumer
product.
3.2.3 failure mode and effects analysis (FMEA)—(FMEA), n—structured approach to identifying potential failures that may exist
within the design of a product or process that result in a physical safety hazard or non-compliance with an end product safety
standard.
3.2.3.1 Discussion—
Failure modes are the ways in which a process can fail. Effects are the ways that these failures can lead to defects, or harmful
outcomes for the customer.
3.2.4 fault tree analysis, n—deductive procedure used to determine the various combinations of hardware and software failures
and human errors that could cause undesired events at the system level.
3.2.5 safety-by-design principle, n—concept intended for product designers to apply in order to achieve a safe product through
implementing hazard identification, risk assessment, and risk control processes at each stage of the design process by considering
and documenting reasonably foreseeable use of the product and taking measures to either eliminate hazards or minimize risks as
early in the design life cycle as possible or provide a default on-product fail safety fail-safe mode.
3.2.6 smart, adj—term indicating that an item is a connected product.
3.2.7 software patch, n—publicly released software update to repair one or more known bugs or issues.
4. Significance and Use
4.1 This guide is intended to apply in conjunction with applicable end product specific end-product specific performance or design
standard requirements to address the overall system safety of a connected consumer product. This guide is not a substitute for the
performance requirements in the end product standard. Designers and manufacturers of a connected consumer product, with
assistance from conformity assessment bodies, or others, as deemed desirable, should identify applicable and relevant product
standards. They should assess and document if or how connectivity potentially affects the ability of such products to meet overall
product-safety requirements, as well as conflicts or requirements, if any, that may or should not be applicable to the connected
consumer product. This guide recognizes that the overall system safety of the connected consumer product is the primary objective.
F3463 − 21
Property damage, including non-functionality of the connected consumer product, is only included to the extent that such property
damage leads to a safety issue. poses a risk of personal injury. Data security beyond the extent necessary to ensure system safety,
or privacy-related issues, are not addressed in this gu
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