SIST EN IEC 61512-1:2026

Batch control - Part 1: Models and terminology (IEC 61512-1:2026)

IEC 61512-1:2026 applies to systems, specifications, and their use for implementing batch and related procedure-oriented manufacturing controls in the process industries. This document establishes a reference model framework for procedure-oriented control, defines terms to help explain the model relationships and usage, and describes general criteria for evaluating conformance. This follows the principle of separation between recipe procedural elements and equipment procedural elements enabling operations to define recipes without the need of changes in equipment procedures.
This second edition cancels and replaces the first edition published in 1997. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) Models and text are modified to provide more detail and clarity. Key clarifications are:
1) Two types of equipment modules are defined: generic and recipe-aware. All recipe-aware equipment modules contain procedural control and can be used as phases in the recipe.
2) Execution of all procedural control contained directly in units is part of the Unit Supervision activity.
3) The relationships between types of recipes, recipe components, and equipment control are more fully described and illustrated.
4) Entity relationship diagrams have been replaced with more intuitive UML instance diagrams, except for the equipment entity model.
5) The transition diagram for the procedural states example has been updated with a more intuitive and complete UML state diagram.
6) References to other standards in the series and to IEC 62264 are included to provide direction for further clarification of selected topics.
7) Activity names are capitalised to help prevent confusion with similar terms, such as their underlying functions.
b) Previous Clauses 4 through 6 (now Clauses 4 through 8) were rearranged to provide a clearer top-down organisation of the document. Key changes are:
1) Removing the lower levels of the physical (role-based equipment) model (see 4.4.2) to eliminate redundancy because their groupings are defined by the associated functionality in the equipment entity model and are not meaningful for batch control without those associations.
2) Describing equipment control and the equipment entity model immediately after the physical (role-based equipment) model and describing each level as completely as possible without excessive use of forward references (see 4.4.3).
3) Combining the descriptions of basic, procedural, and coordination control with their usage in each type of equipment entity, providing a single consolidated discussion of each type of control (see Clause 5)
4) Additional considerations to support application of the models have been grouped in Clause 7 to clarify their supporting relationship to the core models.
c) Clause 9 was added to define completeness, compliance, and conformance in relation to this document.
d) Annex B was added to provide a more expansive procedural state reference model. The model found in Clause 7 can be considered a collapsed version of this more general model.
e) Annex C was added to clarify a number of points concerning the models, their application, and the new Clause 9 on conformance and compliance.
f) Annex E was added to more fully describe the changes in this update to IEC 61512-1:1997.

Chargenorientierte Fahrweise - Teil 1: Modelle und Terminologie (IEC 61512-1:2026)

Contrôle-commande des processus de fabrication par lots - Partie 1: Modèles et terminologie (IEC 61512-1:2026)

IEC 61512-1:2026 s'applique aux systèmes, aux spécifications et à leur utilisation pour la mise en œuvre de commandes de fabrication orientées lots et vers les procédures connexes dans les industries de transformation. Le présent document établit un cadre de modèle de référence pour les commandes orientées procédures, définit des termes pour expliquer plus facilement les relations et l'utilisation du modèle, et décrit des critères généraux pour l'évaluation de la conformité de l'application. Cela suit le principe de séparation entre les éléments de procédure de recette et les éléments de procédure d'équipement, ce qui permet aux opérations de définir des recettes sans qu'il soit nécessaire de modifier les procédures d'équipement.
Cette deuxième édition annule et remplace la première édition parue en 1997. Cette édition constitue une révision technique.
Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) Les modèles et le texte sont modifiés afin de fournir plus de détails et de clarté. Les principales clarifications suivantes ont été effectuées:
1) Deux types de modules d'équipement sont définis: modules d'équipement génériques et modules d'équipement spécifiques aux recettes. Tous les modules d'équipement spécifiques aux recettes comportent une automatisation de procédure et peuvent être utilisés comme des phases dans la recette.
2) L'exécution de toutes les automatisations de procédures contenues directement dans les unités relève de l'activité Supervision d'unité.
3) Les relations entre les types de recettes, les composants des recettes et la commande d'équipement sont décrites et représentées de manière plus détaillée.
4) Les schémas entité-relation ont été remplacés par des diagrammes d'instance UML plus intuitifs, à l'exception du modèle d'entités d'équipement.
5) Le schéma de transition d'états pour l'exemple d'états de procédure a été mis à jour avec un schéma d'états UML plus intuitif et complet.
6) Des références à d'autres normes de la série et à l'IEC 62264 sont incluses afin de fournir des indications permettant de clarifier certains sujets.
7) La première lettre des noms d'activités est écrite en majuscule pour éviter toute confusion avec des termes similaires, comme leurs fonctions sous-jacentes.
b) Les Articles 4 à 6 de la version précédente (désormais numérotés Articles 4 à 8) ont été réorganisés afin de fournir une organisation descendante plus claire du document. Les principales modifications suivantes ont été apportées:
1) Suppression des niveaux inférieurs du modèle physique (équipements fondés sur les rôles) (voir le 4.4.2) pour éliminer la redondance, car leurs regroupements sont définis par la fonctionnalité associée dans le modèle d'entités d'équipement et ne sont pas pertinents pour le contrôle-commande des processus de fabrication par lots sans ces associations.
2) Description de la commande d'équipement et du modèle d'entités d'équipement immédiatement après le modèle physique (équipements fondés sur les rôles) et description la plus complète possible de chaque niveau sans abuser des références directes (voir le 4.4.3).
3) Association des descriptions concernant les commandes de base, les automatisations des procédures et les automatismes de coordination, à leur utilisation dans chaque type d'entité d'équipement, permettant ainsi une discussion consolidée unique sur ch

Nadzor šarže - 1. del: Modeli in terminologija (IEC 61512-1:2026)

IEC 61512-1:2026 se uporablja za sisteme, specifikacije in njihovo uporabo pri izvajanju serijskih in sorodnih postopkovno usmerjenih proizvodnih kontrol v procesni industriji. Ta dokument vzpostavlja referenčni modelni okvir za postopkovno usmerjeno kontrolo, opredeljuje izraze za pomoč pri razlagi odnosov in uporabe modela ter opisuje splošna merila za ocenjevanje skladnosti. To sledi načelu ločevanja med recepturnimi postopkovnimi elementi in postopkovnimi elementi opreme, kar omogoča definiranje receptov brez potrebe po spremembah v postopkih opreme.
Ta druga izdaja razveljavlja in nadomešča prvo izdajo, objavljeno leta 1997. Ta izdaja predstavlja tehnično revizijo.
Ta izdaja vključuje naslednje pomembne tehnične spremembe glede na prejšnjo izdajo:
a) Modeli in besedilo so spremenjeni za zagotavljanje več podrobnosti in jasnosti. Ključne razjasnitve so:
1) Določeni sta dve vrsti modulov opreme: generični in receptno zavedni. Vsi receptno zavedni moduli opreme vsebujejo postopkovno kontrolo in se lahko uporabljajo kot faze v receptu.
2) Izvajanje vse postopkovne kontrole, ki je neposredno vsebovana v enotah, je del aktivnosti Nadzor enote.
3) Odnosi med vrstami receptov, komponentami receptov in kontrolo opreme so podrobneje opisani in ilustrirani.
4) Diagrami entitetnih odnosov so bili nadomeščeni z bolj intuitivnimi UML diagrami primerov, razen za model entitet opreme.
5) Diagram prehodov za primer stanj postopkov je bil posodobljen z bolj intuitivnim in popolnim UML diagramom stanj.
6) Vključene so reference na druge standarde v seriji in na IEC 62264 za zagotavljanje smernic za nadaljnjo razjasnitev izbranih tem.
7) Imena aktivnosti so napisana z veliko začetnico, da bi preprečili zmedo s podobnimi izrazi, kot so njihove osnovne funkcije.
b) Prejšnje točke 4 do 6 (zdaj točke 4 do 8) so bile preurejene za zagotavljanje bolj jasne organizacije dokumenta od zgoraj navzdol. Ključne spremembe so:
1) Odstranitev nižjih ravni fizičnega (na vlogah temelječega opreme) modela (glej 4.4.2) za odpravo redundantnosti, ker so njihove skupine opredeljene s povezano funkcionalnostjo v modelu entitet opreme in niso smiselne za serijsko kontrolo brez teh povezav.
2) Opis kontrole opreme in modela entitet opreme takoj po fizičnem (na vlogah temelječem opreme) modelu in opis vsake ravni čim bolj popolno brez pretirane uporabe referenc naprej (glej 4.4.3).
3) Združevanje opisov osnovne, postopkovne in koordinacijske kontrole z njihovo uporabo v vsaki vrsti entitete opreme, kar zagotavlja enotno združeno razpravo o vsaki vrsti kontrole (glej točko 5).
4) Dodatni premisleki za podporo uporabi modelov so združeni v točki 7 za pojasnitev njihove podporne povezave z osnovnimi modeli.
c) Dodana je bila točka 9 za opredelitev popolnosti, skladnosti in konformnosti v zvezi s tem dokumentom.
d) Dodan je bil Priloga B za zagotavljanje bolj obsežnega referenčnega modela stanj postopkov. Model, ki ga najdemo v točki 7, se lahko šteje za strnjeno različico tega bolj splošnega modela.
e) Dodan je bil Priloga C za pojasnitev številnih točk glede modelov, njihove uporabe in nove točke 9 o konformnosti in skladnosti.
f) Dodan je bil Priloga E za bolj popoln opis sprememb v tej posodobitvi na IEC 61512-1:1997.

General Information

• Status: Published
• Public Enquiry End Date: 25-Apr-2024
• Publication Date: 13-May-2026
• ICS: 01.040.25 - Manufacturing engineering (Vocabularies)
• ICS: 25.040.40 - Industrial process measurement and control
• ICS: 35.240.50 - IT applications in industry
• Technical Committee: MOV - Measuring equipment for electromagnetic quantities
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 07-Apr-2026
• Due Date: 12-Jun-2026
• Completion Date: 14-May-2026
• Ref Project: EN IEC 61512-1:2026 - Batch control - Part 1: Models and terminology

Relations

• Referred By: SIST EN 62264-1:2013 - Enterprise system integration - Part 1: Models and terminology (IEC 62264-1:2013)
• Effective Date: 07-Apr-2026
• Referred By: SIST EN 61512-4:2010 - Batch control - Part 4: Batch production records (IEC 61512-4:2009)
• Effective Date: 07-Apr-2026
• Revises: SIST EN 61512-1:2001 - Batch control -- Part 1: Models and terminology
• Effective Date: 26-Apr-2022

Overview

SIST EN IEC 61512-1:2026 – Batch Control – Part 1: Models and Terminology is an internationally recognized standard developed by CLC and IEC, focused on procedure-oriented manufacturing controls within the process industries. This standard provides a comprehensive reference model and establishes key terminology to support the specification, implementation, and operation of batch control systems.

SIST EN IEC 61512-1:2026 aims to enhance clarity and consistency in the design, management, and communication of batch control procedures. By distinguishing between recipe procedural elements and equipment procedural elements, it allows organizations to define and manage recipes independently from equipment-specific procedures, promoting operational flexibility and easier updates.

Key Topics

• Reference Model Framework
  Establishes a structured framework for defining and understanding batch control processes, supporting consistent application across the process industries.

• Batch Control Terminology
  Defines essential terms and relationships for batch processing, such as batch, recipe, procedural control, equipment entity, and coordination control.

  • Differentiates between generic and recipe-aware equipment modules.
  • Clarifies roles of basic, procedural, and coordination control.

• Recipe and Equipment Models

  • Explains the separation of recipe procedural elements (product-specific instructions) from equipment procedural elements (machine operations).
  • Illustrates how recipes can be managed separately, reducing the need for changes in equipment logic when recipes change.

• Control Activities and Functions

  • Outlines tasks like Recipe Management, Unit Supervision, Production Planning, and Exception Handling.
  • Details the conformance criteria and the importance of model completeness and compliance.

• Updated Diagrams and Structural Clarity
  Incorporates intuitive UML instance and state diagrams, modernizing the presentation of relationships within batch control systems for better comprehension.

Applications

SIST EN IEC 61512-1:2026 is vital for organizations involved in the design, engineering, and operation of batch manufacturing plants in industries such as pharmaceuticals, chemicals, food and beverage, and consumer goods. Practical applications include:

• Batch Manufacturing System Specification

  • Enables engineers and control system vendors to define batch processes using a clear, standardized approach.
  • Supports the modular development of batch automation solutions, facilitating recipe changes without significant reprogramming of equipment.

• Recipe Management and Change Control

  • Allows operations teams to create, modify, and manage recipes independently from equipment-level procedures, minimizing downtime and supporting rapid product changeovers.

• Vendor and User Integration

  • Improves communication and expectation alignment between end-users and automation suppliers.
  • Reduces lifecycle engineering costs by promoting reusable, modular batch control functionality.

• Conformance and Compliance

  • Provides general criteria for assessing system conformance to the standard, assisting with procurement, validation, and audit processes.

• Knowledge Transfer and Training

  • Facilitates knowledge sharing by establishing a consistent terminology and hierarchical structure for batch control concepts and activities.

Related Standards

SIST EN IEC 61512-1:2026 is part of a broader family of standards for batch process control. Related documents include:

• IEC 61512 Series:

  • IEC 61512-2: Data Structures and Guidelines for Languages
  • IEC 61512-3: General and Site Recipe Models and Representation
  • IEC 61512-4: Batch Production Records

• IEC 62264 Series: Enterprise-control system integration, focusing on models and terminology for integration with enterprise-level systems.

• ISO 15704: Industrial automation systems – Requirements for enterprise-reference architectures.

• IEC 60050-351: International Electrotechnical Vocabulary for control technology.

These standards collectively support the digital transformation and integration of batch production across industrial enterprises, enabling robust and compliant batch process management.

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Keywords: batch control, batch process, recipe management, equipment control, process industries, IEC 61512-1, batch manufacturing, procedure-oriented control, industrial automation, terminology, reference model, compliance, CLC, process automation standards, UML diagrams, modular control.

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2026
Nadzor šarže - 1. del: Modeli in terminologija (IEC 61512-1:2026)
Batch control - Part 1: Models and terminology (IEC 61512-1:2026)
Chargenorientierte Fahrweise - Teil 1: Modelle und Terminologie (IEC 61512-1:2026)
Contrôle-commande des processus de fabrication par lots - Partie 1: Modèles et
terminologie (IEC 61512-1:2026)
Ta slovenski standard je istoveten z: EN IEC 61512-1:2026
ICS:
01.040.25 Izdelavna tehnika (Slovarji) Manufacturing engineering
(Vocabularies)
25.040.40 Merjenje in krmiljenje Industrial process
industrijskih postopkov measurement and control
35.240.50 Uporabniške rešitve IT v IT applications in industry
industriji
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 61512-1

NORME EUROPÉENNE
EUROPÄISCHE NORM April 2026
ICS 25.040.40; 01.040.25 Supersedes EN 61512-1:1999
English Version
Batch control - Part 1: Models and terminology
(IEC 61512-1:2026)
Contrôle-commande des processus de fabrication par lots Chargenorientierte Fahrweise - Teil 1: Modelle und
(batch) - Partie 1: Modèles et terminologie Terminologie
(IEC 61512-1:2026) (IEC 61512-1:2026)
This European Standard was approved by CENELEC on 2026-03-27. 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 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 CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 61512-1:2026 E

European foreword
The text of document 65A/1178/FDIS, future edition 2 of IEC 61512-1, prepared by SC 65A "System
aspects" of IEC/TC 65 "Industrial-process measurement, control and automation" was submitted to the
IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 61512-1:2026.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2027-04-30
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2029-04-30
document have to be withdrawn
This document supersedes EN 61512-1:1999 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 61512-1:2026 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standard indicated:
IEC 61512-1:1997 NOTE Approved as EN 61512-1:1999 (not modified)
IEC 61512-2 NOTE Approved as EN 61512-2
IEC 61512-3 NOTE Approved as EN 61512-3
IEC 61512-4 NOTE Approved as EN 61512-4
IEC 62264 (series) NOTE Approved as EN IEC 62264 (series)
IEC 62264-1 NOTE Approved as EN 62264-1
IEC 62264-3 NOTE Approved as EN 62264-3
IEC 62682 NOTE Approved as EN IEC 62682
IEC 63303 NOTE Approved as EN IEC 63303
IEC 61511 (series) NOTE Approved as EN 61511 (series)

IEC 61512-1 ®
Edition 2.0 2026-02
INTERNATIONAL
STANDARD
Batch control -
Part 1: Models and terminology
ICS 25.040.40; 01.040.25 ISBN 978-2-8327-1031-9

IEC 61512-1:2026-02(en)
IEC 61512-1:2026 © IEC 2026
CONTENTS
FOREWORD . 6
INTRODUCTION . 9
1 Scope . 11
2 Normative references . 11
3 Terms, definitions, abbreviated terms and acronyms . 11
3.1 Terms and definitions . 11
3.2 Abbreviated terms and acronyms . 18
4 Batch processes and equipment . 19
4.1 General . 19
4.2 Types of manufacturing . 19
4.2.1 General. 19
4.2.2 Continuous process manufacturing . 19
4.2.3 Discrete parts manufacturing . 19
4.2.4 Batch process manufacturing . 20
4.3 Process model . 20
4.3.1 General. 20
4.3.2 Process . 21
4.3.3 Process stage. 21
4.3.4 Process operation . 21
4.3.5 Process action . 22
4.3.6 Collapsing and expanding the process model . 22
4.4 Equipment and equipment control . 22
4.4.1 General. 22
4.4.2 Role-Based Equipment model . 23
4.4.3 Equipment entity model . 25
4.5 Process cell classification . 33
4.5.1 General. 33
4.5.2 Classification by number of products . 33
4.5.3 Classification by role-based equipment structure . 33
5 Structure for batch control . 35
5.1 General . 35
5.2 Basic control . 36
5.2.1 General. 36
5.2.2 Basic control in equipment entities . 36
5.3 Procedural control . 37
5.3.1 General. 37
5.3.2 Procedural control model . 38
5.3.3 Process model/procedural control model/equipment entity model
relationship . 40
5.3.4 Procedural control in equipment entities . 42
5.4 Coordination control . 43
5.4.1 General. 43
5.4.2 Allocation and arbitration . 43
5.4.3 Coordination control in equipment entities . 44
6 Recipes and procedural elements . 45
6.1 General . 45
IEC 61512-1:2026 © IEC 2026
6.2 Recipe types . 45
6.2.1 General. 45
6.2.2 General recipe . 46
6.2.3 Site recipe . 47
6.2.4 Master recipe . 47
6.2.5 Control recipe . 48
6.3 Recipe contents. 48
6.3.1 General. 48
6.3.2 Header . 48
6.3.3 Formula . 48
6.3.4 Equipment requirements . 49
6.3.5 Procedure . 49
6.3.6 Other information . 50
6.4 Recipe components . 50
6.5 Recipe procedures by type of recipe . 51
6.5.1 General. 51
6.5.2 General recipe procedure . 51
6.5.3 Site recipe procedure . 52
6.5.4 Master recipe procedure . 52
6.5.5 Control recipe procedure . 54
6.6 Control recipe procedure/equipment control relationship . 55
6.6.1 General. 55
6.6.2 Linking recipes and equipment entities . 55
6.6.3 Linking recipe phases and equipment phases . 56
6.6.4 Linking recipe procedural elements and equipment procedural elements
above the phase level. 57
6.6.5 Control recipe procedure/equipment control collapsibility . 62
6.6.6 Linking recipe procedural elements and equipment procedural elements
when using an expanded procedural control model . 63
7 Batch control considerations . 63
7.1 General . 63
7.2 Process and control engineering tasks . 63
7.3 Modes and states . 65
7.3.1 General. 65
7.3.2 Modes . 65
7.3.3 States . 66
7.4 Exception handling . 67
7.5 Example procedural state model . 68
7.5.1 General. 68
7.5.2 Procedural states . 70
7.5.3 Procedural commands . 71
7.6 Batch schedules . 72
7.6.1 General. 72
7.6.2 Campaign . 73
7.7 Production information . 73
7.7.1 General. 73
7.7.2 Batch-specific information . 73
7.7.3 Common (non-batch specific) batch information . 74
7.7.4 Batch history . 74
IEC 61512-1:2026 © IEC 2026
7.7.5 Batch reports . 75
8 Activities and functions in batch control. 75
8.1 General . 75
8.2 Control activity model . 75
8.2.1 General. 75
8.2.2 Information handling . 76
8.3 Recipe Management . 78
8.3.1 General. 78
8.3.2 Manage general recipes . 78
8.3.3 Define general recipe procedural elements . 79
8.3.4 Manage site recipes . 79
8.3.5 Manage master recipes . 79
8.3.6 Define master recipe procedural elements . 80
8.4 Production Planning and Scheduling . 81
8.5 Production Information Management . 81
8.5.1 General. 81
8.5.2 Receiving and storing batch history information. 82
8.5.3 Manipulating historical data . 85
8.5.4 Producing batch reports . 85
8.6 Process Cell Management . 86
8.6.1 General. 86
8.6.2 Manage batches . 88
8.6.3 Track and allocate process cell resources . 89
8.6.4 Collect batch and process cell information . 90
8.7 Unit Supervision . 90
8.7.1 General. 90
8.7.2 Acquire and execute procedural elements . 91
8.7.3 Manage unit resources . 92
8.7.4 Collect batch and unit information . 92
8.8 Process Control . 93
8.8.1 General. 93
8.8.2 Execute equipment procedural control. 94
8.8.3 Execute basic control . 94
8.8.4 Collect data . 94
8.9 Personnel and Environmental Protection . 95
9 Completeness, compliance, and conformance . 95
9.1 Completeness . 95
9.2 Compliance . 96
9.3 Conformance. 96
Annex A (informative) Model philosophy . 97
Annex B (informative) Reference procedural state model . 98
B.1 General . 98
B.2 Procedural states . 103
B.3 Procedural commands . 105
B.4 Using collapsed or expanded versions of the Reference Procedural State
Model . 105
Annex C (informative) Frequently asked questions . 107
C.1 Conformance and compliance . 107
IEC 61512-1:2026 © IEC 2026
C.2 Batch manufacturing roles . 107
C.3 Exception handling details . 108
C.4 Further description of basic control . 109
C.5 Further description of equipment modules . 110
C.6 Recipe building blocks . 111
C.7 Processing a recipe . 111
C.8 Multiple batches through units . 112
Annex D (informative) Software entities explanation . 113
D.1 General . 113
D.2 Enhanced PID configurations . 113
D.3 Advanced process control . 113
D.4 Virtual (soft) sensors based on a single measurement . 113
D.5 Virtual (soft) sensors based on multiple measurements . 113
D.6 Permanent software interlocks . 113
D.7 Data validity checking, data reduction, etc. algorithms . 114
Annex E (informative) Overview of IEC 61512-1:2025 changes . 115
E.1 General . 115
E.2 Key clarifications . 115
E.3 Changes in definitions . 116
E.4 Changes in structure . 116
E.5 Changes in models . 120
E.5.1 What has been updated . 120
E.5.2 What has been added . 125
E.5.3 What has been removed . 127
E.6 Other changes . 128
E.7 Summary . 128
Bibliography . 129

Figure 1 – Process model (instance diagram) when not collapsed or expanded . 21
Figure 2 – Example of Role-Based Equipment model . 24
Figure 3 – Equipment entity model . 26
Figure 4 – Equipment entity model example 1 . 32
Figure 5 – Equipment entity model example 2 . 32
Figure 6 – Single-path structure . 33
Figure 7 – Multiple-path structure . 34
Figure 8 – Network structure . 35
Figure 9 – Procedural control model (instance diagram) when not collapsed or
expanded . 38
Figure 10 – Typical process/procedure/equipment mapping to achieve process
functionality . 41
Figure 11 – Recipe types model . 46
Figure 12 – Master recipe component encapsulation . 50
Figure 13 – General recipe procedure model . 52
Figure 14 – Master recipe procedure model. 53
Figure 15 – Information flow from general recipe to equipment entity . 56
Figure 16 – Control recipe procedure referencing equipment procedural elements at
the phase level . 57
IEC 61512-1:2026 © IEC 2026
Figure 17 – Control recipe referencing equipment procedural elements at the operation
level; equipment procedural control structure undefined . 58
Figure 18 – Control recipe referencing equipment procedural elements at the operation
level; combination implements the full procedural control model . 59
Figure 19 – Control recipe referencing equipment procedural elements at the unit
procedure level; equipment procedural control structure undefined . 59
Figure 20 – Control recipe referencing equipment procedural elements at the unit
procedure level; combination implements the full procedural control model . 60
Figure 21 – Control recipe referencing equipment procedural elements at the
procedure level; equipment procedural control structure undefined . 60
Figure 22 – Control recipe referencing equipment procedural elements at the
procedure level; combination implements the full procedural control model . 61
Figure 23 – Referencing equipment procedural elements at different levels within the
same recipe procedure. 62
Figure 24 – Control recipe procedure/equipment procedure collapsibility examples . 63
Figure 25 – Simultaneous definition/selection of procedural elements and equipment
entities . 64
Figure 26 – State transition diagram for example states for procedural elements. 69
Figure 27 – Control activity model . 76
Figure 28 – Recipe Management . 78
Figure 29 – Process Cell Management. 87
Figure 30 – Unit Supervision . 91
Figure 31 – Process Control . 93
Figure B.1 – State transition diagram for the reference procedural state model . 101
Figure E.1 – Changes in structure (1 of 4) . 117
Figure E.2 – Changes in structure (2 of 4) . 118
Figure E.3 – Changes in structure (3 of 4) . 118
Figure E.4 – Changes in structure (4 of 4) . 119
Figure E.5 – Updated: Process model . 120
Figure E.6 – Updated: Role-based Equipment role . 121
Figure E.7 – Updated: Process cell path structures . 122
Figure E.8 – Updated: Process/procedure/equipment mapping to achieve process
functionality . 123
Figure E.9 – Updated: Recipe types model . 123
Figure E.10 – Updated: Control recipe procedure linking examples . 124
Figure E.11 – Updated: Procedure/equipment procedure collapsibility examples . 124
Figure E.12 – Updated: Example state model . 125
Figure E.13 – Removed: Procedural element relationships in the site recipe and master
recipe . 127
Figure E.14 – Removed: Control recipe procedure/equipment control separation . 127

Table 1 – Example modes . 66
Table 2 – State transition matrix for example states for procedural elements . 70
Table 3 – State descriptions in the example procedural state model . 70
Table B.1 – State transition matrix for the reference procedural state model . 101
Table B.2 – State descriptions in the reference procedural state model . 103
IEC 61512-1:2026 © IEC 2026
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
Batch control -
Part 1: Models and terminology

FOREWORD
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6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
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the latest information, which may be obtained from the patent database available at https://patents.iec.ch. IEC
shall not be held responsible for identifying any or all such patent rights.
IEC 61512-1 has been prepared by subcommittee 65A: System aspects, of IEC technical
committee 65: Industrial-process measurement and control. It is an International Standard.
This second edition cancels and replaces the first edition published in 1997. This edition
constitutes a technical revision.
IEC 61512-1:2026 © IEC 2026
This edition includes the following significant technical changes with respect to the previous
edition:
a) Models and text are modified to provide more detail and clarity. Key clarifications are:
1) Two types of equipment modules are defined: generic and recipe-aware. All recipe-
aware equipment modules contain procedural control and can be used as phases in the
recipe.
2) Execution of all procedural control contained directly in units is part of the Unit
Supervision activity.
3) The relationships between types of recipes, recipe components, and equipment control
are more fully described and illustrated.
4) Entity relationship diagrams have been replaced with more intuitive UML instance
diagrams, except for the equipment entity model.
5) The transition diagram for the procedural states example has been updated with a more
intuitive and complete UML state diagram.
6) References to other standards in the series and to IEC 62264 are included to provide
direction for further clarification of selected topics.
7) Activity names are capitalised to help prevent confusion with similar terms, such as their
underlying functions.
b) Previous Clauses 4 through 6 (now Clauses 4 through 8) were rearranged to provide a
clearer top-down organisation of the document. Key changes are:
1) Removing the lower levels of the physical (role-based equipment) model (see 4.4.2) to
eliminate redundancy because their groupings are defined by the associated
functionality in the equipment entity model and are not meaningful for batch control
without those associations.
2) Describing equipment control and the equipment entity model immediately after the
physical (role-based equipment) model and describing each level as completely as
possible without excessive use of forward references (see 4.4.3).
3) Combining the descriptions of basic, procedural, and coordination control with their
usage in each type of equipment entity, providing a single consolidated discussion of
each type of control (see Clause 5).
4) Additional considerations to support application of the models have been grouped in
Clause 7 to clarify their supporting relationship to the core models.
c) Clause 9 was added to define completeness, compliance, and conformance in relation to
this document.
d) Annex B was added to provide a more expansive procedural state reference model. The
model found in Clause 7 can be considered a collapsed version of this more general model.
e) Annex C was added to clarify a number of points concerning the models, their application,
and the new Clause 9 on conformance and compliance.
f) Annex E was added to more fully describe the changes in this update to IEC 61512-1:1997.
The text of this International Standard is based on the following documents:
Draft Report on voting
65A/1178/FDIS 65A/1197/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
IEC 61512-1:2026 © IEC 2026
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications.
In this standard, the following print type is used:
Defined terms are italicised in the body of this document to avoid misinterpretation based on
meanings outside of the IEC 61512 series.
A list of all parts in the IEC 61512 series, published under the general title Batch control, can
be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
– reconfirmed,
– withdrawn, or
– revised.
IEC 61512-1:2026 © IEC 2026
INTRODUCTION
The IEC 61512 series of standards comprises several parts. This document describes an
overarching framework of models and definitions for batch manufacturing. Other parts of the
series describe in more detail particular focus areas within this framework.
All IEC documents follow a fixed structure consisting of Clause 1 “Scope”, Clause 2 “Normative
references” and Clause 3 “Terms and definitions”. This document therefore contains a
Normative references clause even if it is empty.
Clause 3 provides terms and definitions that are important for the understanding of certain terms
used in the document. Each definition can be considered a summary statement for the
associated term. Since this document defines models and terminology as a whole, all of its
provisions contribute to each term’s full meaning and to its relationship to the models.
Clauses 4 through 8 incrementally complete these definitions by starting at a very high level,
progressively detailing a set of conceptual models, and describing how they collectively interact
to control of a production of a batch. The models are presumed to be complete as indicated.
However, they can be collapsed and expanded as described in the explanation of each model.
Clause 4 Batch processes and equipment is normative. The intent of this clause is to provide
models and terminology that describe batch processes and the equipment used to perform
them.
Clause 5 Structure for batch control is normative. The intent is to describe three types of control
used in batch processing and their relationships to the previously defined process and
equipment models.
Clause 6 Recipes and procedural elements is normative. The intent is to describe the roles and
contents of four types of recipes used in batch manufacturing, their use of the previously defined
process and procedural control models, and their connection to equipment control.
Clause 7 Batch control considerations is normative. The intent is to describe additional
considerations related to iterative design, exception handling, modes and states, production
plans and schedules, and production information.
Clause 8 Activities and functions in batch control is normative. The intent is to describe the
control activities that are necessary to address the diverse control requirements of batch
manufacturing.
Clause 9 Completeness, compliance, and conformance is normative. The intent is to define
compliance and conformance relative to the normative models and terminology in this
document.
Annex A is informative. It provides guidance towards understanding the model types used in
this document. Usage of UML instance diagrams and state diagrams is described in Annex A
and contrasted with the corresponding figures of IEC 61512-1:1997 as shown in Annex E.
Annex B is informative. It provides a more expansive procedural state reference model. The
model found in 7.5 can be considered a collapsed version of this more general model.
Annex C is informative. It provides answers to typical questions that can arise in applying this
document.
Annex D is informative. It provides further explanation of the software entities listed in 4.2.
IEC 61512-1:2026 © IEC 2026
Annex E is informative. It provides a summary of the changes made in this update as compared
with IEC 61512-1:1997.
The bibliography is informative, giving references for further investigation concerning safety
and other relevant standards.
This document is intended for those who are
• involved in the design, operation, or both of batch manufacturing plants,
• responsible for specifying controls and the associated application programs for batch
manufacturing plants, or
• involved in the design and marketing of products in the area of batch control.
This document defines standard models and terminology for specifying the control requirements
for batch manufacturing plants. The models and terminology
• emphasise good practices for the design and operation of batch manufacturing plants,
• can be used to improve control of batch manufacturing plants, and
• can be applied regardless of the degree of automation.
This document provides standard terminology and a consistent set of concepts and models for
batch manufacturing plants and batch control that are intended to
• improve communications between all parties involved,
• reduce the user's time to reach full production levels for new products,
• enable vendors to supply appropriate tools for implementing batch control,
• enable users to better identify their needs,
• make recipe development straightforward enough to be accomplished without the services
of a control systems engineer,
• reduce the cost of automating batch processes, and
• reduce life-cycle engineering efforts
...