Space product assurance - Safety

This Standard defines the safety programme and the safety technical requirements aiming to protect flight and ground personnel, the launch vehicle, associated payloads, ground support equipment, the general public, public and private property, the space system and associated segments and the environment from hazards associated with European space systems.
This Standard is applicable to all European space projects.
This standard may be tailored for the specific characteristic and constraints of a space project in conformance with ECSS-S-ST-00.

Raumfahrtsysteme - Sicherheit

Systèmes spatiaux - Sécurité

La présente norme européenne définit le programme de sécurité et les exigences techniques de sécurité qui doivent être mis en œuvre afin de protéger le personnel en vol et au sol, le lanceur, les charges utiles associées, les équipements de support au sol, le public, les biens publics et privés, le système spatial et les segments associés ainsi que l’environnement contre les risques liés aux systèmes spatiaux européens.
La présente norme s’applique à tous les projets spatiaux européens.
La présente norme peut être adaptée aux caractéristiques et contraintes spécifiques à un projet spatial conformément à la norme ECSS-S-ST-00.

Zagotavljanje kakovosti proizvodov v vesoljski tehniki - Varnost

Ta standard opredeljuje varnostni program in varnostno-tehnične zahtev, ki so namenjene zaščiti letalske posadke in osebja na zemlji, rakete, povezanih tovorov, podporne opreme na tleh, splošne javnosti, javne in zasebne lastnine, vesoljskega sistema in povezanih segmentov ter okolja pred nevarnostmi, ki so povezane z evropskimi vesoljskimi sistemi. Ta standard se uporablja za vse evropske vesoljske projekte. Ta standard se lahko prilagodi posameznim lastnostim in omejitvam vesoljskega projekta v skladu s standardom ECSS-S-ST-00.

General Information

Status
Published
Public Enquiry End Date
31-Jul-2017
Publication Date
13-May-2018
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
07-May-2018
Due Date
12-Jul-2018
Completion Date
14-May-2018

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SLOVENSKI STANDARD
SIST EN 16602-40:2018
01-julij-2018
1DGRPHãþD
SIST EN ISO 14620-1:2004
Zagotavljanje kakovosti proizvodov v vesoljski tehniki - Varnost
Space product assurance - Safety
Raumfahrtsysteme - Sicherheit
Systèmes spatiaux - Sécurité
Ta slovenski standard je istoveten z: EN 16602-40:2018
ICS:
49.140 Vesoljski sistemi in operacije Space systems and
operations
SIST EN 16602-40:2018 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 16602-40:2018
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SIST EN 16602-40:2018
EUROPEAN STANDARD
EN 16602-40
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2018
ICS 49.140
Supersedes EN ISO 14620-1:2002
English version
Space product assurance - Safety
Assurance produit des projets spatiaux - Sécurité Raumfahrtsysteme - Sicherheit
This European Standard was approved by CEN on 18 September 2017.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for

giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical

references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to

any CEN and CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC

Management Centre has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,

Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany,

Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,

Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels

© 2018 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN 16602-40:2018 E

reserved worldwide for CEN national Members and for
CENELEC Members.
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SIST EN 16602-40:2018
EN 16602-40:2018 (E)
Table of contents

European Foreword ................................................................................................... 7

1 Scope ....................................................................................................................... 9

2 Normative references ........................................................................................... 10

3 Terms, definitions and abbreviated terms .......................................................... 11

3.1 Terms from other standards .................................................................................... 11

3.2 Terms specific to the present standard ................................................................... 11

3.3 Abbreviated terms................................................................................................... 13

3.4 Nomenclature ......................................................................................................... 14

4 Safety principles ................................................................................................... 15

4.1 Objective ................................................................................................................ 15

4.2 Policy ...................................................................................................................... 15

4.2.1 General ..................................................................................................... 15

4.2.2 Implementation ......................................................................................... 15

4.3 Safety programme .................................................................................................. 16

5 Safety programme ................................................................................................ 17

5.1 Scope ..................................................................................................................... 17

5.2 Safety programme plan .......................................................................................... 17

5.3 Conformance .......................................................................................................... 18

5.4 Safety organization ................................................................................................. 18

5.4.1 Safety manager ......................................................................................... 18

5.4.2 Safety manager access and authority ....................................................... 18

5.4.3 Safety audits ............................................................................................. 19

5.4.4 Approval of documentation ........................................................................ 19

5.4.5 Approval of hazardous operations ............................................................. 19

5.4.6 Representation on boards ......................................................................... 19

5.4.7 Safety approval authority........................................................................... 20

5.5 Safety risk assessment and control ........................................................................ 20

5.6 Safety critical items ................................................................................................. 20

5.7 Project phases and safety review cycle .................................................................. 20

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SIST EN 16602-40:2018
EN 16602-40:2018 (E)

5.7.1 Safety program tasks and reviews ............................................................ 20

5.7.2 Progress meetings .................................................................................... 24

5.7.3 Safety reviews ........................................................................................... 24

5.8 Safety compliance demonstration ........................................................................... 25

5.9 Safety training ......................................................................................................... 25

5.9.1 General ..................................................................................................... 25

5.9.2 Product specific training ............................................................................ 25

5.9.3 General awareness briefings ..................................................................... 26

5.9.4 Basic technical training ............................................................................. 26

5.9.5 Training records ........................................................................................ 26

5.10 Accident-incident reporting and investigation .......................................................... 26

5.11 Safety documentation ............................................................................................. 26

5.11.1 General ..................................................................................................... 26

5.11.2 Safety data package ................................................................................. 27

5.11.3 Safety deviations and waivers ................................................................... 27

5.11.4 Safety lessons learned .............................................................................. 28

5.11.5 Documentation of safety critical items ....................................................... 28

6 Safety engineering ............................................................................................... 29

6.1 Overview ................................................................................................................ 29

6.2 Safety requirements identification and traceability .................................................. 29

6.3 Safety design objectives ......................................................................................... 29

6.3.1 Safety policy and principles ....................................................................... 29

6.3.2 Design selection ........................................................................................ 29

6.3.3 Hazard reduction precedence ................................................................... 30

6.3.4 Environmental compatibility ....................................................................... 32

6.3.5 External services ....................................................................................... 32

6.3.6 Hazard detection - signalling and safing .................................................... 32

6.3.7 Space debris mitigation ............................................................................. 33

6.3.8 Atmospheric re-entry ................................................................................. 33

6.3.9 Safety of Earth return missions ................................................................. 33

6.3.10 Safety of human spaceflight missions ....................................................... 34

6.3.11 Access ...................................................................................................... 34

6.4 Safety risk reduction and control ............................................................................. 34

6.4.1 Severity of hazardous event and function criticality ................................... 34

6.4.2 Failure tolerance requirements .................................................................. 36

6.4.3 Design for minimum risk ............................................................................ 37

6.4.4 Probabilistic safety targets ........................................................................ 38

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SIST EN 16602-40:2018
EN 16602-40:2018 (E)

6.5 Identification and control of safety-critical functions ................................................ 39

6.5.1 Identification .............................................................................................. 39

6.5.2 Inadvertent operation ................................................................................ 39

6.5.3 Status information ..................................................................................... 39

6.5.4 Safe shutdown and failure tolerance requirements .................................... 39

6.5.5 Electronic, electrical, electromechanical components ................................ 40

6.5.6 Software functions..................................................................................... 40

6.6 Operational Safety .................................................................................................. 42

6.6.1 Basic requirements ................................................................................... 42

6.6.2 Flight operations and mission control ........................................................ 42

6.6.3 Ground operations .................................................................................... 43

7 Safety analysis requirements and techniques ................................................... 46

7.1 Overview ................................................................................................................ 46

7.2 General ................................................................................................................... 46

7.3 Assessment and allocation of requirements ............................................................ 47

7.3.1 Safety requirements .................................................................................. 47

7.3.2 Additional safety requirements .................................................................. 47

7.3.3 Define safety requirements - functions ...................................................... 47

7.3.4 Define safety requirements - subsystems .................................................. 47

7.3.5 Justification ............................................................................................... 47

7.3.6 Functional and subsystem specification .................................................... 47

7.4 Safety analyses during the project life cycle............................................................ 47

7.5 Safety analyses ...................................................................................................... 48

7.5.1 General ..................................................................................................... 48

7.5.2 Hazard analysis ........................................................................................ 48

7.5.3 Safety risk assessment ............................................................................. 49

7.5.4 Supporting assessment and analysis ........................................................ 49

8 Safety verification ................................................................................................. 53

8.1 General ................................................................................................................... 53

8.2 Hazard reporting and review ................................................................................... 53

8.2.1 Hazard reporting system ........................................................................... 53

8.2.2 Safety status review .................................................................................. 53

8.2.3 Documentation .......................................................................................... 53

8.3 Safety verification methods ..................................................................................... 54

8.3.1 Verification engineering and planning ....................................................... 54

8.3.2 Methods and reports ................................................................................. 54

8.3.3 Analysis .................................................................................................... 54

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SIST EN 16602-40:2018
EN 16602-40:2018 (E)

8.3.4 Inspections ................................................................................................ 54

8.3.5 Verification and approval ........................................................................... 55

8.4 Verification of safety-critical functions ..................................................................... 55

8.4.1 Validation .................................................................................................. 55

8.4.2 Qualification .............................................................................................. 55

8.4.3 Failure tests .............................................................................................. 56

8.4.4 Verification of design or operational characteristics ................................... 56

8.4.5 Safety verification testing .......................................................................... 56

8.5 Hazard close-out .................................................................................................... 56

8.5.1 Safety assurance verification .................................................................... 56

8.5.2 Hazard close-out verification ..................................................................... 57

8.6 Declaration of conformity of ground equipment ....................................................... 57

Annex A (informative) Analyses applicability matrix ........................................... 58

Annex B (normative) Safety programme plan - DRD ............................................ 60

B.1 DRD identification ................................................................................................... 60

B.1.1 Requirement identification and source document ...................................... 60

B.1.2 Purpose and objective ............................................................................... 60

B.2 Expected response ................................................................................................. 60

B.2.1 Contents ................................................................................................... 60

B.2.2 Special remarks ........................................................................................ 61

Annex C (normative) Safety verification tracking log (SVTL) DRD ..................... 62

C.1 DRD identification ................................................................................................... 62

C.1.1 Requirement identification and source document ...................................... 62

C.1.2 Purpose and objective ............................................................................... 62

C.2 Expected response ................................................................................................. 62

C.2.1 Contents ................................................................................................... 62

C.2.2 Special remarks ........................................................................................ 64

Annex D (normative) Safety analysis report including hazard reports -

DRD ...................................................................................................................... 66

D.1 DRD identification ................................................................................................... 66

D.1.1 Requirement identification and source document ...................................... 66

D.1.2 Purpose and objective ............................................................................... 66

D.2 Expected response ................................................................................................. 66

D.2.1 Contents ................................................................................................... 66

D.2.2 Special remarks ........................................................................................ 67

Annex E (informative) Criteria for probabilistic safety targets ............................ 68

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SIST EN 16602-40:2018
EN 16602-40:2018 (E)

E.1 Objectives of probabilistic safety targets ................................................................. 68

E.2 Criteria for probabilistic safety targets ..................................................................... 68

Annex F (informative) Applicability guidelines ..................................................... 69

Annex G (informative) European legislation and ‘CE’ marking ........................... 75

G.1 Overview ................................................................................................................ 75

G.2 CE mark ................................................................................................................. 75

G.3 Responsibility of the design authority ...................................................................... 75

G.4 Declaration of conformity ........................................................................................ 76

G.5 References ............................................................................................................. 76

Bibliography ............................................................................................................. 78

Figures

Figure C-1 : Safety verification tracking log (SVTL) .............................................................. 65

Tables

Table 6-1: Severity categories .............................................................................................. 36

Table 6-2: Criticality of functions ........................................................................................... 36

Table 6-3: Criticality category assignment for software products vs. function criticality ......... 41

Table A-1 : Safety deliverable documents ............................................................................ 59

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SIST EN 16602-40:2018
EN 16602-40:2018 (E)
European Foreword

This document (EN 16602-40:2018) has been prepared by Technical Committee CEN/CLC/JTC 5

“Space”, the secretariat of which is held by DIN (Germany).
This document (EN 16602-40:2018) originates from ECSS-Q-ST-40C Rev.1.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by October 2018, and conflicting national standards shall

be withdrawn at the latest by October 2018.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such

patent rights.
This document supersedes EN ISO 14620-1:2002.
The main changes with respect to EN ISO 14620-1:2002 are listed below:
• new EN number,

• Complete and thorough review with the focus on simplification and streamlining to improve

clarity and consistency of requirements.

• Applicability guidelines to the different space systems has been defined (see applicability matrix

provided in Annex E).

• System safety programme requirements reworked, i.e. the system safety programme supports the

risk management process described in EN 16601-80 (based on ECSS-M-ST-80C).
• Space debris mitigation streamlined.
• Atmospheric re-entry addressed.
• Safety design principles reworked.
• Safety risk reduction and control updated.
• Safety analysis requirements and techniques updated.

• Common scheme for consequence severity classification used in EN 16602-30 and EN 16602-40

(based on ECSS-Q-ST-30C and ECSS-Q-ST-40C).
• Identification and control of safety-critical functions updated.

• Established link to EN 1602-10-04 “Critical-item control” (based on ECSS-Q-ST-10-04).

• Informative annex on European legislation and ‘CE’ marking added (Annex F).
• DRDs revisited and updated.
• Document reworked to be in compliance with ECSS standards drafting rules.
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SIST EN 16602-40:2018
EN 16602-40:2018 (E)

This document has been prepared under a standardization request given to CEN by the European

Commission and the European Free Trade Association.

This document has been developed to cover specifically space systems and has therefore precedence

over any EN covering the same scope but with a wider domain of applicability (e.g. : aerospace).

According to the CEN-CENELEC Internal Regulations, the national standards organisations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of

Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia,

Spain, Sweden, Switzerland, Turkey and the United Kingdom.
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SIST EN 16602-40:2018
EN 16602-40:2018 (E)
Scope
This Standard defines the safety programme and the safety technical
requirements aiming to protect flight and ground personnel, the launch vehicle,
associated payloads, ground support equipment, the general public, public and
private property, the space system and associated segments and the
environment from hazards associated with European space systems.
This Standard is applicable to all European space projects.

This standard may be tailored for the specific characteristic and constraints of a

space project in conformance with ECSS-S-ST-00.
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SIST EN 16602-40:2018
EN 16602-40:2018 (E)
Normative references
The following normative documents contain provisions which, through
reference in this text, constitute provisions of this ECSS Standard. For dated
references, subsequent amendments to, or revision of any of these publications
do not apply. However, parties to agreements based on this ECSS Standard are

encouraged to investigate the possibility of applying the more recent editions of

the normative documents indicated below. For undated references, the latest
edition of the publication referred to applies.
EN reference Reference in text Title
EN 16601-00-01 ECSS-S-ST-00-01 ECSS system – Glossary of terms
EN 16603-10 ECSS-E-ST-10 Space engineering – System engineering general
requirements
EN 16603-32-01 ECSS-E-ST-32-01 Space engineering – Fracture control

EN 16603-32-10 ECSS-E-ST-32-10 Space engineering – Structural factors of safety for

spaceflight hardware
EN 16603-40 ECSS-E-ST-40 Space engineering – Software general requirements
EN 16601-10 ECSS-M-ST-10 Space project management – Project planning and
implementation
EN 16601-40 ECSS-M-ST-40 Space project management – Configuration and
information management
EN 16601-80 ECSS-M-ST-80 Space project management – Risk management
EN 16602-10 ECSS-Q-ST-10 Space product assurance – Product assurance
management
EN 16602-10-04 ECSS-Q-ST-10-04 Space product assurance – Critical-item control
EN 16602-20 ECSS-Q-ST-20 Space product assurance – Quality assurance
EN 16602-30 ECSS-Q-ST-30 Space product assurance – Dependability
EN 16602-60 ECSS-Q-ST-60 Space product assurance – Electrical, electronic and
electromechanical (EEE) components
EN 16602-70 ECSS-Q-ST-70 Space product assurance – Materials, mechanical parts
and processes
EN 16602-80 ECSS-Q-ST-80 Space product assurance – Software product assurance
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SIST EN 16602-40:2018
EN 16602-40:2018 (E)
Terms, definitions and abbreviated terms
3.1 Terms from other standards
a. For the purpose of this Standard, the terms and definitions from ECSS-S-
ST-00-01 apply (see in clause 3.2 differences for "fail safe" and "system"),
in particular for the following terms:
1. accident
2. failure
3. catastrophic
4. critical
5. emergency
6. ground segment
7. hazard
8. hazardous event
9. inhibit
10. risk
11. safety
12. safing
13. severity
14. safety-critical function
15. space segment
16. system
3.2 Terms specific to the present standard
3.2.1 cause

action or condition by which a hazardous event is initiated (an initiating event)

NOTE 1 The cause can arise as the result of failure,
human error, design inadequacy, induced or
natural environment, system configuration or
operational mode(s).
NOTE 2 This definition is specific to this Standard,
when used in the context of hazard analysis.
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SIST EN 16602-40:2018
EN 16602-40:2018 (E)
3.2.2 criticality

classification of a function or of a software, hardware or operation according to

the severity of the consequences of its potential failures
NOTE 1 Refer to clauses 6.4.1 and 6.5.6.
NOTE 2 This notion of criticality, applied to a function
or a software, hardware or operation, considers
only severity, differently from the criticality of a
failure or failure mode (or a risk), which also
considers the likelihood or probability of
occurrence.
3.2.3 fail safe

property of a system (or part of it), which prevents its failures from resulting in

critical or catastrophic consequences
3.2.4 hazard control
preventive or mitigation measure, associated to a hazard scenario, which is
introduced into the system design and operation to avoid the events or to
interrupt their propagation to consequence
3.2.5 hazardous command
command that can remove an inhibit to a safety-critical function or activate a
hazardous subsystem
3.2.6 hazard reduction
process of elimination or minimization and control of hazards
3.2.7 hazard scenario
sequence of events leading from the initial cause to the unwanted safety
consequence
NOTE The cause can be a single initiating event, or an
additional action or a change of condition
activating a dormant problem.
3.2.8 operator error
failure of an operator to perform an action as required or trained or the
inadvertent or incorrect action of an operator
3.2.9 safety approval authority
entity that defines or makes applicable, for a given project, detailed technical
safety requirements, and reviews their implementation
3.2.10 safety audit
independent examination to determine whether the procedures specific to the
safety requirements are implemented effectively and are suitable to achieve the
specified objectives
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SIST EN 16602-40:2018
EN 16602-40:2018 (E)
3.2.11 safety risk
measure of the threat to safety posed by the hazard scenarios and their
consequences
NOTE 1 Safety risk is always associated with a specific
hazard scenario or a particular set of scenarios.
The risk posed by a single scenario is called
individual scenario risk. The risk posed by a set
of scenarios with the same top consequence is
called overall risk.
NOTE 2 The magnitude of a safety risk is a combination
of the severity and the likelihood of the
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